ASEPXIA ACNE TREATMENT- benzoyl peroxide cream

Asepxia Acne Treatment by

Drug Labeling and Warnings

Asepxia Acne Treatment by is a Otc medication manufactured, distributed, or labeled by Genomma Lab USA Inc., Garcoa, Inc., Sigan Industries INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Brnzoyl Peroxide 10%

Purpose

Acne Treatment

Uses

• ♦ for the treatment of acne
• ♦ dries and clears acne blemishes
• ♦ penetrates pores to eliminate most acne blemishes
• ♦ helps prevent new acne blemishes

Warnings

For external use only

Do not use

• ♦ if you have very sensitive skin
• ♦ if you are sensitive to benzoyl peroxide

When using this product

• ♦ avoid unnecessary sun exposure and use a sunscreen
• ♦ avoid contact with eyes, lips and mouth
• ♦ avoid contact with hair and dyed fabrics, which may be bleached by this product
• ♦ skin irritation and dryness is more likely to occur if you use another acne medication at the same time. If irritation occurs, use only one topical acne medication at a time
• ♦ skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. Irritation may be reduced by using this product less frequently or at a lower concentration

Stop use and ask a doctor if

• ♦ irritation becomes 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 or 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

Sensitivity test for new user

• ♦ apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above

Other information

• ♦ Keep tightly closed
• ♦ Store at room temperature

Inactive ingredients

carbomer, disodium EDTA, hydroxypropyl methylcellulose, Laureth-4, sodium hydroxide, water

Questions or comments?

1 877 99 GENOM (43666)

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Distributed by: Genomma Lab USA Inc., Houston, TX 77027

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

NEW LOOK

Asepxia®

ACNE TREATMENT CREAM

10% BENZOYL PEROXIDE

> ELIMINATES MOST PIMPLES AND BLACKHEADS

NET WT.
1 OZ (28 g)

INGREDIENTS AND APPEARANCE

ASEPXIA ACNE TREATMENT 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-052
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)	Benzoyl Peroxide	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Carboxypolymethylene (UNII: 0A5MM307FC)
Edetate Disodium (UNII: 7FLD91C86K)
Hypromellose, Unspecified (UNII: 3NXW29V3WO)
Laureth-4 (UNII: 6HQ855798J)
Sodium Hydroxide (UNII: 55X04QC32I)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-052-01	1 in 1 CARTON	03/06/2015
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	03/06/2015

Labeler - Genomma Lab USA Inc. (832323534)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Garcoa, Inc.		036464697	MANUFACTURE(50066-052)