Keralyt

Summers Laboratories Inc

FULL PRESCRIBING INFORMATION

Keralyt^® Gel
(salicylic acid) 6%
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.

DESCRIPTION: KERALYT^® is a gel for topical administration containing salicylic acid 6%, in a vehicle composed of propylene glycol, SD-40 alcohol (21%), hydroxypropylcellulose and purified water. Salicylic acid is the 2 hydroxy derivative of benzoic acid having the following structure:

CLINICAL PHARMACOLOGY: Salicylic acid has been shown to produce desquamation of the horny layer of skin while not affecting qualitative or quantitative changes in structure of the viable epidermis.¹ ^, ² The mechanism of action has been attributed to a dissolution of intercellular cement substance.³ In a study of the percutaneous absorption of salicylic acid from KERALYT GEL in four patients with extensive active psoriasis, Taylor and Halprin⁴ showed that peak serum salicylate levels never exceeded 5 mg/100 ml even though more than 60% of the applied salicylic acid was absorbed. Systemic toxic reactions are usually associated with much higher serum levels (30 to 40 mg/100 ml). Peak serum levels occurred within 5 hours of the topical application under occlusion. The sites were occluded for 10 hours over the entire body surface below the neck. Since salicylates are distributed in the extracellular space, patients with a contracted extracellular space due to dehydration or diuretics have higher salicylate levels than those with a normal extracellular space.⁵ (See PRECAUTIONS). The major metabolites identified in the urine after topical administration are salicyluric acid (52%), salicylate glucuronides (42%), and free salicylic acid (6%).⁴ The urinary metabolites after percutaneous absorption differ from those after oral salicylate administration; those derived from percutaneous absorption contain more glucuronides and less salicyluric and salicylic acid. Almost 95% of a single dose of salicylate is excreted within 24 hours of its entrance into the extracellular space.⁵ Fifty to eighty percent of salicylate is protein bound to albumin. Salicylates compete with the binding of several drugs and can modify the action of these drugs. By similar competitive mechanisms other drugs can influence the serum levels of salicylate.⁵ (See PRECAUTIONS).

Uses

INDICATIONS AND USAGE - For the removal of excess keratin in hyperkeratotic disorders, including scaling associated with scalp psoriasis or thickened skin of palms and soles, corns and calluses.

CONTRAINDICATIONS: KERALYT GEL should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredient. KERALYT should not be used in children under 2 years of age.

WARNINGS: Prolonged use over large areas, especially in children and those patients with significant renal or hepatic impairment, could result in salicylism. Concomitant use of other drugs which may contribute to elevated serum salicylate levels should be avoided where the potential for toxicity is present. In children under 12 years of age and those patients with renal or hepatic impairment, the area to be treated should be limited and the patient monitored closely for signs of salicylate toxicity: nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnoea, diarrhea, psychic disturbances. In the event of salicylic acid toxicity, the use of KERALYT GEL should be discontinued. Fluids should be administered to promote urinary excretion. Treatment with sodium bicarbonate (oral or intravenous) should be instituted as appropriate. Considering the potential risk of developing Reye's Syndrome, salicylate products should not be administered to children or teenagers with varicella or influenza, unless directed by a physician.

PRECAUTIONS: For external use only. Avoid contact with eyes and other mucous membranes. Mild burning or stinging may occur. Peeling of the skin may increase as the salicylic acid works to loosen excess keratin. If excessive burning, stinging or peeling occurs, discontinue use and consult your physician. Flammable. Keep away from heat and open flame. Keep this and all medications out of reach of children.

Drug Interactions. (The following interactions are from a published review⁵ and include reports concerning both oral and topical salicylate administration. The relationship of these interactions to the use of KERALYT GEL is not known.)

I. Due to the competition of salicylate with other drugs for binding to serum albumin the following drug interactions may occur:

II. Drugs changing salicylate levels by altering renal tubular reabsorption:

III. Drugs with complicated interactions with salicylates:

The following alterations of laboratory tests have been reported during salicylate therapy⁶:

Pregnancy (Category C): Salicylic acid has been shown to be teratogenic in rats and monkeys. It is difficult to extrapolate from oral doses of acetyl salicylic acid used in these studies to topical administration as the oral dose to monkeys may represent 4 times the maximum daily human dose of salicylic acid (as supplied in one tube, 40 g of KERALYT GEL) when applied topically over a large body surface. There are no adequate and well-controlled studies in pregnant women. KERALYT GEL should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

Nursing Mothers: Because of the potential for serious adverse reactions in nursing infants from the mother’s use of KERALYT GEL, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Carcinogenesis, Mutagenesis, Impairment of Fertility: No data are available concerning potential carcinogenic or reproductive effects of KERALYT GEL. It has been shown to lack mutagenic potential in the Ames Salmonella test.

ADVERSE REACTIONS: Excessive erythema and scaling conceivably could result from use on open skin lesions.

OVERDOSAGE - See WARNINGS

DOSAGE AND ADMINISTRATION - The preferable method of use is to apply KERALYT GEL thoroughly to the affected area and occlude the area at night. Preferably, the skin should be hydrated for at least five minutes prior to application. The medication is washed off in the morning and if excessive drying and/or irritation is observed a bland cream or lotion may be applied. Once clearing is apparent, the occasional use of KERALYT GEL will usually maintain the remission. In those areas where occlusion is difficult or impossible, application may be made more frequently; hydration by wet packs or baths prior to application apparently enhances the effect. Unless hands are being treated, hands should be rinsed thoroughly after application. For use as a scalp treatment: KERALYT GEL should be applied directly to the affected areas of the scalp on a frequency directed by your physician. The applicator tip will provide accurate application, avoiding contact with normal hair or skin. The gel should be washed off after 10 to 20 minutes initially, but it can be left on for up to an hour as treatment progresses. The gel can be washed off using KERALYT SHAMPOO or warm water in a bath or shower.

HOW SUPPLIED: 60 g Plastic bottle NDC 11086-030-60
Store at controlled room temperature 59° to 86° F (15° to 30° C)

REFERENCES:

• Davies M, Marks R: Br J Dermatol 95: 187-192,1976.
• Marks R, Davies M, Cattel A: J Invest Dermatol 64: 283, 1975.
• Huber C, Christophers E: Arch Derm Res 257: 293-297, 1977.
• Taylor JR, Halprin KM: Arch Dermatol 111: 740-743, 1975.
• Goldsmith LA: Int J Dermatol 18: 32-36.
• Wilson JG, Ritter EJ, Scott WJ, Fradlein R: Tox Appl Pharmacol 41: 67-78, 1977.

SUMMERS LABORATORIES INC
Manufactured by:
EMS Contract Packaging, Hatfield, PA 19440
Distributed by:
Summers Laboratories, Inc. Collegeville, PA 19426
1-800-533-SKIN (7546) • www.sumlab.com
KERALYT is a trademark of Summers Laboratories, Inc.

Keralyt^® Shampoo
(salicylic acid) 6%
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.

DESCRIPTION: KERALYT^® shampoo contains 6% w/w salicylic acid USP in a vehicle composed of purified water, ammonium lauryl sulfosuccinate, cocamidopropyl betaine, hexylene glycol, linoleamidopropyl PG-dimonium chloride phosphate, polyquaternium-22, propylene glycol, sodium C14-16 olefin sulfonate, sodium citrate, sodium lauroyl sarcosinate, tetrasodium EDTA, tocopherol acetate and fragrance. Salicylic acid is the 2 hydroxy derivative of benzoic acid having the following structure:

CLINICAL PHARMACOLOGY: Salicylic acid has been shown to produce desquamation of the horny layer of skin while not affecting qualitative or quantitative changes in structure of the viable epidermis.¹ ^, ² The mechanism of action has been attributed to a dissolution of intercellular cement substance.³ In a study of the percutaneous absorption of salicylic acid in four patients with extensive active psoriasis, Taylor and Halprin⁴ showed that peak serum salicylate levels never exceeded 5 mg/100 ml even though more than 60% of the applied salicylic acid was absorbed. Systemic toxic reactions are usually associated with much higher serum levels (30 to 40 mg/100 ml). Peak serum levels occurred within 5 hours of the topical application under occlusion. The sites were occluded for 10 hours over the entire body surface below the neck. Since salicylates are distributed in the extracellular space, patients with a contracted extracellular space due to dehydration or diuretics have higher salicylate levels than those with a normal extracellular space.⁵ (See PRECAUTIONS). The major metabolites identified in the urine after topical administration are salicyluric acid (52%), salicylate glucuronides (42%), and free salicylic acid (6%).⁴ The urinary metabolites after percutaneous absorption differ from those after oral salicylate administration; those derived from percutaneous absorption contain more glucuronides and less salicyluric and salicylic acid. Almost 95% of a single dose of salicylate is excreted within 24 hours of its entrance into the extracellular space.⁵ Fifty to eighty percent of salicylate is protein bound to albumin. Salicylates compete with the binding of several drugs and can modify the action of these drugs. By similar competitive mechanisms other drugs can influence the serum levels of salicylate.⁵ (See PRECAUTIONS).

Uses

INDICATIONS AND USAGE - For the removal of excess keratin in hyperkeratotic disorders, including scaling associated with scalp psoriasis or thickened skin of palms and soles, corns and calluses.

CONTRAINDICATIONS: KERALYT SHAMPOO should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredient. KERALYT SHAMPOO should not be used in children under 2 years of age.

WARNINGS: Prolonged use over large areas, especially in children and those patients with significant renal or hepatic impairment, could result in salicylism. Concomitant use of other drugs which may contribute to elevated serum salicylate levels should be avoided where the potential for toxicity is present. In children under 12 years of age and those patients with renal or hepatic impairment, the area to be treated should be limited and the patient monitored closely for signs of salicylate toxicity: nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnoea, diarrhea, psychic disturbances. In the event of salicylic acid toxicity, the use of KERALYT SHAMPOO should be discontinued. Fluids should be administered to promote urinary excretion. Treatment with sodium bicarbonate (oral or intravenous) should be instituted as appropriate. Considering the potential risk of developing Reye's Syndrome, salicylate products should not be administered to children or teenagers with varicella or influenza, unless directed by a physician.

PRECAUTIONS: For external use only. Avoid contact with eyes and other mucous membranes. Mild burning or stinging may occur. Peeling of the skin may increase as the salicylic acid works to loosen excess keratin. If excessive burning, stinging or peeling occurs, discontinue use and consult your physician. Keep this and all medications out of reach of children.

Drug Interactions. (The following interactions are from a published review⁵ and include reports concerning both oral and topical salicylate administration. The relationship of these interactions to the use of KERALYT SHAMPOO is not known.)

I. Due to the competition of salicylate with other drugs for binding to serum albumin the following drug interactions may occur:

II. Drugs changing salicylate levels by altering renal tubular reabsorption:

III. Drugs with complicated interactions with salicylates:

The following alterations of laboratory tests have been reported during salicylate therapy⁶:

Pregnancy (Category C): Salicylic acid has been shown to be teratogenic in rats and monkeys. It is difficult to extrapolate from oral doses of acetyl salicylic acid used in these studies to topical administration as the oral dose to monkeys may represent 4 times the maximum daily human dose of salicylic acid (as supplied in one bottle, 8 oz. of KERALYT SHAMPOO) when applied topically over a large body surface. There are no adequate and well-controlled studies in pregnant women. KERALYT SHAMPOO should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

Nursing Mothers: Because of the potential for serious adverse reactions in nursing infants from the mother’s use of KERALYT SHAMPOO, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. If used by nursing mothers, it should not be in the chest area in order to avoid accidental exposure to a nursing child.

Carcinogenesis, Mutagenesis, Impairment of Fertility: No data are available concerning potential carcinogenic or reproductive effects of KERALYT SHAMPOO. It has been shown to lack mutagenic potential in the Ames Salmonella test.

ADVERSE REACTIONS: Excessive erythema and scaling conceivably could result from use on open skin lesions.

OVERDOSAGE - See WARNINGS

DOSAGE AND ADMINISTRATION - For use as a concentrated scalp treatment BEFORE bathing: Do not wet hair. Twist open applicator tip and apply KERALYT SHAMPOO w/applicator evenly, directly to affected areas of the scalp. Leave on for 5 minutes, gradually increasing treatment time up to one hour, or as directed by physician. Wash hands after applying KERALYT SHAMPOO w/applicator. After treatment, rinse thoroughly with water. Although no additional shampoo is needed to cleanse hair, a non-medicated shampoo may be used if desired. For use as a medicated shampoo: Wet hair and apply KERALYT SHAMPOO w/applicator to the scalp. Work into a lather, leave on for several minutes, then rinse. Use daily until the condition clears. After clearing is apparent, use KERALYT SHAMPOO w/applicator occasionally to maintain clearing or as directed by your physician.

HOW SUPPLIED: 160 mL plastic bottles NDC 11086-043-06
Store at controlled room temperature 59° to 86° F (15° to 30° C)

REFERENCES:

• Davies M, Marks R: Br J Dermatol 95: 187-192,1976.
• Marks R, Davies M, Cattel A: J Invest Dermatol 64: 283, 1975.
• Huber C, Christophers E: Arch Derm Res 257: 293-297, 1977.
• Taylor JR, Halprin KM: Arch Dermatol 111: 740-743, 1975.
• Goldsmith LA: Int J Dermatol 18: 32-36.
• Wilson JG, Ritter EJ, Scott WJ, Fradlein R: Tox Appl Pharmacol 41: 67-78, 1977.

SUMMERS LABORATORIES INC
Manufactured by:
EMS Contract Packaging, Hatfield, PA 19440
Distributed by:
Summers Laboratories, Inc. Collegeville, PA 19426
1-800-533-SKIN (7546) • www.sumlab.com
KERALYT is a trademark of Summers Laboratories, Inc.

Package Label - Principal Display Panel - Keralyt Scalp Carton