EQUATE MAXIMUM STRENGTH SPOT TREATMENT - benzoyl peroxide gel 
Wal-Mart Stores 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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drug facts

Section from Carton Label Follows:

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


Uses

- Treats acne - dries up acne pimples - helps prevent new acne pimples


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 1 to 3 times daily
- because excessive drying of the skin may occur, start with one application daily,
then gradually increase to 2 or 3 times daily if needed or as directed by a doctor
- if bothersome dryness or peeling occurs, reduce application too once a day or every other day

Other Information

- keep tightly closed. Avoid storing at extreme temperature - below
4 degrees C or above 37 degrees C (below 40 degrees F or above 100 degrees F)
- lot no. and exp. date, see product container or box

Questions?

Call 1-888-287-1915

Warnings
For external use only.

Do not use
- on broken skin - on large areas of the body
- if you have very sensitive skin or if you are sensitive to benzoyl peroxide

When using this product - apply to the affected area only - avoid unnecessary sun
exposure and use a sunscreen - this product may bleach hair or dyed fabrics - using
other topical acne medications at the same time or immediately following use of this
product may increase dryness or irritation of the skin. If this occurs, only one medication
should be used unless directed by a doctor - keep away from eyes, lips, mouth and
sensitive areas of the neck

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 1 to 3 times daily
- because excessive drying of the skin may occur, start with one application daily,
then gradually increase to 2 or 3 times daily if needed or as directed by a doctor
- if bothersome dryness or peeling occurs, reduce application too once a day or every other day


Inactive Ingredients carbomer, diethylhexyl sodium sulfosuccinate, disodium EDTA,
purified water, sodium hydroxide


c


EQUATE MAXIMUM STRENGTH SPOT TREATMENT 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-022
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE135 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
EDETATE SODIUM (UNII: MP1J8420LU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-022-031 in 1 CARTON
118.4 g in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333D07/13/2010
Labeler - Wal-Mart Stores Inc (051957769)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 2/2011
Document Id: e6837d64-e885-4999-b481-dcebb1aed420
Set id: 718f4e2d-76ff-4684-95cf-68fb13b9057f
Version: 1
Effective Time: 20110204
 
Wal-Mart Stores Inc