KERALYT description, usages, side effects, indications, overdosage, supplying and lots more!

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KERALYT

Summers Laboratories Inc




FULL PRESCRIBING INFORMATION

Active ingredient

CONTAINS

SALICYLIC ACID 5%

Purpose

PURPOSE

SKIN SOFTENER

Uses

USES

  • HELPS EXFOLIATE ROUGH OR SCALY SCALP

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT AVOID CONTACT WITH THE EYES. IF EYE CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

DO NOT USE ON IRRITATED, INFECTED OR OPEN SKIN.

STOP USE AND ASK A DOCTOR IF

  • REDNESS, DISCOMFORT OR IRRITATION OCCUR FOLLOWING USE OF THIS PRODUCT

KEEP OUT OF REACH OF CHILDREN

IF SWALLOWED, GET MEDICAL HELP OR CONTCT A POISON CONTROL CENTER RIGHT AWAY.

FLAMMABLE

KEEP AWAY FROM HEAT AND OPEN FLAME.

Directions

For use as a concentrated scalp therapy

BEFORE bathing: Do not wet hair. Twist open applicator tip and apply Keralyt 5 Shampoo evenly, directly to affected areas of the scalp. Leave on for 5 minutes for the first application, gradually increasing contact time up to one hour, or as directed by your healthcare provider. Wash hands after applying Keralyt 5 Shampoo. After application, rinse hair thoroughly with water. Although no additional shampoo is needed to cleanse hair, a non-medicated shampoo may be used if desired. Use daily until you are satisfied with the appearance of your scalp. Use occasionally as needed to maintain, or use as directed by your healthcare provider.

For use as a medicated shampoo: Wet hair and apply a liberal amount of Keralyt 5 Shampoo and massage into a lather. Leave on for several minutes, then rinse. Use daily until you are satisfied with the appearance of your scalp. Use occasionally as needed to maintain, or use as directed by your healthcare provider.

Ingredients

purified water, ammonium lauryl sulfosuccinate, cocamidopropyl betaine, salicylic acid, 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.

Store at controlled room temperature

59° to 86° F (15° to 30° C)

KERALYT

KERALYT

salicylic acid SHAMPOO

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11086-052
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Salicylic Acid SALICYLIC ACID 5 g

Inactive Ingredients

Ingredient Name Strength
water
AMMONIUM LAURATE
COCAMIDOPROPYL BETAINE
Hexylene Glycol
LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE
POLYQUATERNIUM-22 (4500 MPA.S)
propylene glycol
SODIUM C14 OLEFIN SULFONATE
SODIUM CITRATE
SODIUM LAUROYL SARCOSINATE
EDETATE SODIUM
.ALPHA.-TOCOPHEROL ACETATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11086-052-05 177 in 1 BOTTLE
2 NDC:11086-052-55 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partH part358H 2013-10-30


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