Benzoyl Peroxide Emollient

BENZOYL PEROXIDE EMOLLIENT- benzoyl peroxide aerosol, foam
Metacon Labs

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

DESCRIPTION

Each gram of Benzoyl Peroxide 5.3% Emollient Foam contains 5.3% benzoyl peroxide in an aqueous based emollient foam vehicle containing BHT, C12-15 alkyl benzoate, cetearyl alcohol, citric acid, dimethicone, disodium EDTA, emulsifying wax, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, steareth-10. Also contains: Propellant HFA-134a (1,1,1,2-tetrafluoroethane).

Benzoyl peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic. Benzoyl peroxide (C14 H10 O4 ) is represented by the following structure:

Structural Formula
(click image for full-size original)

CLINICAL PHARMACOLOGY

The exact method of action of benzoyl peroxide in acne vulgaris is not known. Benzoyl peroxide is an antibacterial agent with demonstrated activity against Propionibacterium acnes. This action, combined with the mild keratolytic effect of benzoyl peroxide, is believed to be responsible for its usefulness in acne. Benzoyl peroxide is absorbed by the skin where it is metabolized to benzoic acid and excreted as benzoate in the urine.

INDICATIONS AND USAGE

Benzoyl Peroxide 5.3% Emollient Foam is indicated for use in the topical treatment of mild to moderate acne vulgaris.

CONTRAINDICATIONS

Benzoyl Peroxide 5.3% Emollient Foam should not be used in patients who have shown hypersensitivity to benzoyl peroxide or to any of the other ingredients in the product. Discontinue use if hypersensitivity is observed.

WARNINGS

FOR EXTERNAL USE ONLY. Not for ophthalmic use. Keep out of the reach of children.

When using this product, skin irritation and dryness is more likely to occur if:

you leave Benzoyl Peroxide 5.3% Emollient Foam on your skin longer than directed
you use another topical acne medication at the same time

If irritation occurs:

use Benzoyl Peroxide 5.3% Emollient Foam less frequently
use one topical acne medication at a time
stop use and ask a doctor if irritation becomes severe

Do not use if you:

have very sensitive skin
are sensitive to benzoyl peroxide

When using this product:

avoid unnecessary sun exposure and use a sunscreen
avoid contact with the eyes, lips, and mouth
avoid contact with hair and dyed fabrics, which may be bleached by this product
skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling

Contents under pressure. Do not puncture or incinerate container. Do not expose to temperature above 120°F (49°C).

PRECAUTIONS

General:

If severe irritation develops, discontinue use and institute appropriate therapy.

Information for Patients:

This medication is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. If excessive redness or irritation develops, discontinue use and consult your physician.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Based upon all available evidence, benzoyl peroxide is not considered to be a carcinogen. However, data from a study using mice known to be highly susceptible to cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of the findings is not known.

Pregnancy:

Category C. Animal reproduction studies have not been conducted with benzoyl peroxide. It is also 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.

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 below the age of 12 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 this 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

Avoid contact with hair, fabrics or carpeting as benzoyl peroxide may cause bleaching or discoloration.

Prime Can Before Initial Use: Gently push up on actuator with thumb until tab breaks. Shake can vigorously (until product moves inside can). Firmly strike bottom of can onto palm of other hand or a hard surface at least 3 times. Holding can upright over sink, direct initial spray to a non-skin surface. Until primed, DO NOT spray directly on the skin as the initial spray may expel cold liquid propellant. Press down on actuator for 1-3 seconds until foam begins to dispense. If foam does not dispense within 3 seconds, prime can again.

Before Each Use: Shake can vigorously. Firmly strike bottom of can onto palm of other hand or a hard surface at least 3 times.

During Use: Holding can upright, dispense Benzoyl Peroxide 5.3% into palm of hand. Cover the entire affected area with a thin layer 1 to 3 times daily. Rub in until completely absorbed.

LEAVE-ON INSTRUCTIONS: Apply product before bed and then wash hands with soap and water. Wear a white t-shirt and use white linens.

WASH-OFF INSTRUCTIONS: Apply product, wait 5 minutes, shower, and dry with a white towel.

Wipe off any excess foam from actuator after use. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day. Wash hands with soap and water after use. If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

HOW SUPPLIED:

Benzoyl Peroxide 5.3% Emollient Foam is supplied in 60g (NDC 49808-194-60) aluminum cans. Will not dispense entire contents. Container is overfilled to guarantee dispensing at least the listed amount. Store at room temperature 59° — 77°F (15° — 25°C). Protect from freezing. Store upright.

MANUFACTURED FOR:

Metacon Labs Logo

Metacon Labs

866-777-4633

www.metaconlabs.com

Patent Pending

P/N 2621 Rev. 0

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — Benzoyl Peroxide Emollient Foam 60 grams Can Label

Rx Only

Benzoyl Peroxide 5.3%

Emollient Foam

NDC 49808-194-60

Net Weight 60g

Benzoyl Peroxide Emollient Foam 60g Can Label
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — Benzoyl Peroxide Emollient Foam 60 grams Carton Label

Rx Only

Benzoyl Peroxide 5.3%

Emollient Foam

NDC 49808-194-60

Net Weight 60g

Benzoyl Peroxide Emollient Foam 60g Carton Label
(click image for full-size original)
BENZOYL PEROXIDE EMOLLIENT
benzoyl peroxide aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49808-194
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 5.3 g in 100 g
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
ALKYL (C12-15) BENZOATE
CETOSTEARYL ALCOHOL
CITRIC ACID MONOHYDRATE
DIMETHICONE
EDETATE DISODIUM
GLYCERIN
METHYLPARABEN
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SODIUM CITRATE, UNSPECIFIED FORM
STEARETH-10
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49808-194-60 1 CAN in 1 CARTON contains a CAN
1 60 g in 1 CAN This package is contained within the CARTON (49808-194-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 04/01/2011 03/31/2016
Labeler — Metacon Labs (793223707)
Registrant — Onset Dermatologics LLC (793223707)
Establishment
Name Address ID/FEI Operations
Metacon Labs 793223707 MANUFACTURE (49808-194)

Revised: 11/2014 Metacon Labs

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