BPO 6 Foaming

Acella Pharmaceuticals, LLC

BPO 6% Foaming Cloths

FULL PRESCRIBING INFORMATION

DESCRIPTION: BPO 3% and 6% Foaming Cloths are topical preparations containing benzoyl peroxide for use in the treatment of acne vulgaris. Benzoyl peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic. Benzoyl peroxide (C14H10O4) is represented by the following chemical structure:

BPO 3% and 6% Foaming Cloths contain, respectively, benzoyl peroxide 3% and 6% as the active ingredient in a cream vehicle containing: cetostearyl alcohol, hydrogenated castor oil, cocamidopropyl betaine, PEG-14M, methyl paraben, mineral oil, purified water, sodium lauryl sulfate, potassium choride, glycolic acid, imidurea, sodium PCA liquid, cornstarch, titanium dioxide, sodium hydroxide, glycerine, dimethyl isosorbide.

CLINICAL PHARMACOLOGY: The mechanism of action of benzoyl peroxide is not totally understood but its antibacterial activity against Propionibacterium acnes is thought to be a major mode of action. In addition, patients treated with benzoyl peroxide show a reduction in lipids and free fatty acids, and mild desquamation (drying and peeling activity) with simultaneous reduction in comedones and acne lesions. Little is known about the percutaneous penetration, metabolism, and excretion of benzoyl peroxide, although it has been shown that benzoyl peroxide absorbed by the skin is metabolized to benzoic acid and then excreted as benzoate in the urine. There is no evidence of systemic toxicity caused by benzoyl peroxide in humans.

Uses

INDICATIONS: BPO 3% and 6% Foaming Cloths are indicated for the topical treatment of acne vulgaris.

CONTRAINDICATIONS: These preparations are contraindicated in patients with a history of hypersensitivity to any of their components.

WARNINGS: When using this product, avoid unnecessary sun exposure and use a sunscreen.  FOR EXTERNAL USE ONLY. Keep away from eyes. Keep container tightly closed.

Keep out of reach of children.

PRECAUTIONS: General - For external use only. If severe irritation develops, discontinue use and institute appropriate therapy. After reaction clears, treatment may often be resumed with less frequent application. These preparations should not be used in or near the eyes or on mucous membranes.

Information for patients - Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. Contact with any colored material (including hair and fabric) may result in bleaching or discoloration. If excessive irritation develops, discontinue use and consult your physician.

Carcinogenesis, Mutagenesis, Impairment of Fertility - Data from several studies employing a strain of mice that are highly susceptible to developing cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of these findings to humans is unknown. Benzoyl peroxide has not been found to be mutagenic (Ames Test) and there are no published data indicating it impairs fertility.

PREGNANCY: Teratogenic Effects - Pregnancy Category C. - Animal reproduction studies have not been conducted with benzoyl peroxide. It is not known whether benzoyl peroxide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzoyl peroxide should be used by a pregnant woman only if clearly needed. There are no available data on the effect of benzoyl peroxide on the later growth, development and functional maturation of the unborn child.

NURSING MOTHERS: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when benzoyl peroxide is administered to a nursing woman.

PEDIATRIC USE: Safety and effectiveness in children have not been established.

ADVERSE REACTIONS:Allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy.

OVERDOSAGE: If excessive scaling, erythema or edema occurs, the use of these preparations should be discontinued. To hasten resolution of the adverse effects, cool compresses may be used. After symptoms and signs subside, a reduced dosage schedule may be cautiously tried if the reaction is judged to be due to excessive use and not allergenicity.

DOSAGE AND ADMINISTRATION: Wash affected areas once or twice daily, or as directed by your physician. Wet face with water. Wet cloth with a little water and work into a full lather. Cleanse face with cloth for 10–20 seconds. Avoid eyes or mucous membranes. Rinse thoroughly and pat dry.

If drying occurs, it may be controlled by rinsing sooner or using less often. Throw away cloth. Do not flush.

HOW SUPPLIED: BPO 3% Foaming Cloths are available in boxes of 60 cloths (3.2g), (NDC 42192-124-60).
BPO 6% Foaming Cloths are available in boxes of 60 cloths (3.2g), (NDC 42192-125-60).

Store at controlled room temperature, 15° - 25°C (59° - 77°F).

All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical formulation information provided herein.

MANUFACTURED FOR: Acella Pharmaceuticals, LLC
9005 Westside Parkway
Alpharetta, GA 30009
1-800-541-4802                                              Rev. 0610

NDC 42192-125-60

BPO 6% Foaming Cloths

Rx only

Net weight 3.2 g each

Acella
Pharmaceuticals, LLC

Contents: benzoyl peroxide USP 6% as an active ingredient in a cream vehicle containing cetostearyl alcohol, hydrogenated castor oil, cocamidopropyl betaine, PEG-14M, methyl paraben, mineral oil, purified water, sodium lauryl sulfate, potassium choride, glycolic acid, imidurea, sodium PCA liquid, cornstarch, titanium dioxide, sodium hydroxide, glycerine, dimethyl isosorbide.

Directions: Wash affecte areas with BPO 6% Foaming cloths once or twice daily, or as directed by your physician.
1. Wet face with water.
2. Wet cloth with a little water and work into a full lather.
3. Cleanse face wuth cloth for 10 - 20 seconds, avoiding eyes and mucous membrances.
4. Rinse thoroughly and pat dry.
5. Discard cloth. Do not flush.
If drying occurs, It may be controlled by rinsing cleanser off sooner or using less often.

Precautions: See Package insert for complete Precautions and Prescribing information. For external use only. Avoid contat with eyes, eyelids, lips ad mucous membranes. If accidental contact occurs, rinse with water, Contact with any colored material (Including hair and fabric) may result in bleaching or discoloration. If excessive irritation develops, discontinue use and consult your physician.

Warnings: KEEP OUT OF REACH OF CHILDREN. When using this product, avoid unnecessary sun exposure and use a sunscreen.
Store at 15 Degree centigrade - 25 Degree C (59 Degree centigrade - 77 Degree F).

All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Please see package insert for more information.

MANUFACTURED FOR:
Acella Pharmaceuticals, LLC
Alpharetta, GA 30009
1-800-541-4802

Rx Only

60 foaming cloths - Net weight 3.2 g each

Acella
Pharmaceuticals, LLC

NDC 42192-125-60

BPO 6% Foaming Cloths

Contents: benzoyl peroxide USP 6% as an active ingredient in a cream vehicle containing cetostearyl alcohol, hydrogenated castor oil, cocamidopropyl betaine, PEG-14M, methyl paraben, mineral oil, purified water, sodium lauryl sulfate, potassium choride, glycolic acid, imidurea, sodium PCA liquid, cornstarch, titanium dioxide, sodium hydroxide, glycerine, dimethyl isosorbide.

Directions: Wash affecte areas with BPO 6% Foaming cloths once or twice daily, or as directed by your physician.
1. Wet face with water.
2. Wet cloth with a little water and work into a full lather.
3. Cleanse face wuth cloth for 10 - 20 seconds, avoiding eyes and mucous membrances.
4. Rinse thoroughly and pat dry.
5. Discard cloth. Do not flush.
If drying occurs, It may be controlled by rinsing cleanser off sooner or using less often.

Precautions: See Package insert for complete Precautions and Prescribing information. For external use only. Avoid contat with eyes, eyelids, lips ad mucous membranes. If accidental contact occurs, rinse with water, Contact with any colored material (Including hair and fabric) may result in bleaching or discoloration. If excessive irritation develops, discontinue use and consult your physician.

Warnings: KEEP OUT OF REACH OF CHILDREN. When using this product, avoid unnecessary sun exposure and use a sunscreen.
Store at 15 Degree centigrade - 25 Degree C (59 Degree centigrade - 77 Degree F).

NDC 42192-125-60

BPO 6% Foaming Cloths

Rx Only

60 foaming cloths - Net weight 3.2 g each

Acella
Pharmaceuticals, LLC

All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable.
NOTE: This is not an Orange Book product. No representation is made as to generic status or bioequivalency. Please see package insert for more information.

MANUFACTURED FOR:
Acella Pharmaceuticals, LLC
9005 Westside Parkway
Alpharetta, GA 30009
1-800-541-4802
Rev.0510v1