ASEPXIA ACNE TREATMENT- benzoyl peroxide cream 
Genomma Lab USA Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Asepxia® Acne Treatment Cream
Acne Treatment

Drug Facts

Active ingredient

Benzoyl 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?

1 877 994 3666. Monday to Friday, 8am to 6pm, Central time.

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

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Asepxia®

ACNE TREATMENT CREAM

10% BENZOYL PEROXIDE

> ELIMINATES MOST PIMPLES AND BLACKHEADS

NET WT./ CONT. NET.
1 OZ (28 g)

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
ASEPXIA ACNE TREATMENT 
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-052
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Edetate Disodium (UNII: 7FLD91C86K)  
Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
Laureth-4 (UNII: 6HQ855798J)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Water (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-052-011 in 1 CARTON03/06/2015
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D03/06/2015
Labeler - Genomma Lab USA Inc. (832323534)
Registrant - Garcoa, Inc. (036464697)
Establishment
NameAddressID/FEIBusiness Operations
Sigan Industries INC255106239MANUFACTURE(50066-052) , LABEL(50066-052) , PACK(50066-052)

Revised: 2/2023
Document Id: a8c78145-5e16-4938-a36a-44b33f629636
Set id: addefc6f-3a0a-4470-a4e8-a9398d354005
Version: 3
Effective Time: 20230214
 
Genomma Lab USA Inc.