EQUATE MAXIMUM STRENGTH SPOT TREATMENT- benzoyl peroxide gel

Equate Maximum Strength Spot Treatment by

Drug Labeling and Warnings

Equate Maximum Strength Spot Treatment by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores Inc, Pharma Pac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Section from Carton Label Follows:

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

PURPOSE

Uses

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison
Control Center right away.

INDICATIONS & USAGE

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

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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EQUATE MAXIMUM STRENGTH SPOT TREATMENT 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	135 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DOCUSATE SODIUM (UNII: F05Q2T2JA0)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-022-03	1 in 1 CARTON
1		18.4 g in 1 BOTTLE, DISPENSING

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333D	07/13/2010

Labeler - Wal-Mart Stores Inc (051957769)

Registrant - Pharma Pac, LLC (140807475)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Pac, LLC		140807475	manufacture