Label: EQUATE MAXIMUM STRENGTH SPOT TREATMENT- benzoyl peroxide gel
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Contains inactivated NDC Code(s)
NDC Code(s): 49035-022-03 - Packager: Wal-Mart Stores Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated February 4, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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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
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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.
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EQUATE MAXIMUM STRENGTH SPOT TREATMENT
benzoyl peroxide gelProduct 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
