BENZOYL PEROXIDE 5% GEL- benzoyl peroxide gel

Benzoyl Peroxide 5% Gel by

Drug Labeling and Warnings

Benzoyl Peroxide 5% Gel by is a Otc medication manufactured, distributed, or labeled by Axia Medical Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

Benzoyl Peroxide 5%

Purpose

Acne Treatment

USES:

For the treatment of acne.

WARNINGS:

For external use only.

Do not use if you:

Have sensitive skin. Are sensitive to benzoyl peroxide.

When using the product:

Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.  If this occurs only use one topical acne medication at a time 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.  Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop use and ask a doctor if:

Irritation become severe.

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Clean the skin thoroughly before applying this product Cover the entire affected area with a thin layer one to three times daily 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 If going outside, apply sunscreen after using this product.  If irritation or sensitivity develops, stop use of both products and ask a doctor.

Inactive Ingredients:

Allantoin, Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Carbomer, Disodium EDTA, Disodium Laureth Sulfosuccinate, Glycerin, Panthenol, PEG-8, PEG-14 Palmeth-60 Hexyl Dicarbamate, Sodium Hyaluronate, Triethanolamine, and Water.

OTHER INFORMATION:

Store at controlled room temperature 15-30°C (59-86°F)

Questions?:

866-494-4466, Mon-Fri 8:00AM-5:00PM

Dist. By Axia Medical Solutions, 2105 Camino Vida Roble, Carlsbad, Ca. 92011

www.dermesse.com     866-494-4466 office, 760-931-8267 fax

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BENZOYL PEROXIDE 5% GEL 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68723-305
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	50 mg  in 1000 mg

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
GLYCERIN (UNII: PDC6A3C0OX)
PANTHENOL (UNII: WV9CM0O67Z)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PPG-14 PALMETH-60 HEXYL DICARBAMATE (UNII: 376C96Y6AL)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68723-305-02	57 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/18/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	07/18/2017

Labeler - Axia Medical Solutions, LLC (929224694)