MAXIMUM STRENGTH ACNE- benzoyl peroxide 10% gel

Maximum Strength Acne by

Drug Labeling and Warnings

Maximum Strength Acne by is a Otc medication manufactured, distributed, or labeled by TopCare, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

INDICATIONS & USAGE

Uses for the treatment of acne

WARNINGS

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

KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH ACNE 
benzoyl peroxide 10% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-878
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	Benzoyl Peroxide	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-878-01	28 g in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	11/01/2011

Labeler - TopCare (006935977)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(36800-878) , label(36800-878)