MAXIMUM STRENGTH ACNE- benzoyl peroxide 10% gel 
TopCare

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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Drug Facts

Active ingredient                                      Purpose
Benzoyl Peroxide 10%.............................Acne Treatment

Uses for the treatment of acne

Warnings
For external use only.
Do not use if you have very sensitive skin or are sensitive to benzoyl peroxide.
When using this product • skin irritation and dryness is more likely to occur if you use another
topical acne medication at the same time. If irritation occurs, only use one topical acne medication
at a time. • rinse right away with water if it gets in eyes • 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 skin irritation becomes severe.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center
right away

Directions • cleanse the skin thoroughly before applying medication • cover the entire
affected area with a thin layer one to three times a day • 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, use a sunscreen. Allow product
to dry, then follow direction in the sunscreen labeling. If sensitivity develops, discontinue use of
both products and consult a doctor.

Inactive ingredients Carbomer, Disodium EDTA, Disodium Lauryl Sulfosuccinate,
Methylparaben, Sodium Hydroxide, Water.

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MAXIMUM STRENGTH ACNE 
benzoyl peroxide 10% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-878
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) Benzoyl Peroxide10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Disodium Lauryl Sulfosuccinate (UNII: P160Q81342)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
Methylparaben (UNII: A2I8C7HI9T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-878-0128 g in 1 BOTTLE; Type 0: Not a Combination Product11/01/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D11/01/2011
Labeler - TopCare (006935977)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(36800-878) , label(36800-878)

Revised: 6/2018
Document Id: d554ecdc-959d-4a96-89e0-0c8c5eb45678
Set id: e71eb901-8d52-4313-910b-fb8afa0da99f
Version: 1
Effective Time: 20180625
 
TopCare