Otc - Active Ingredient
Section from Carton Label Follows:Active ingredient PurposeBenzoyl Peroxide, 10%...............................Acne Treatment
Equate Maximum Strength Spot Treatment
FDA Label NDC 49035-022
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores Inc for the product Equate Maximum Strength Spot Treatment (NDC 49035-022). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses- Treats acne - dries up acne pimples - helps prevent new acne pimples
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a PoisonControl 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 peroxideWhen 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 - usingother topical acne medications at the same time or immediately following use of thisproduct may increase dryness or irritation of the skin. If this occurs, only one medicationshould be used unless directed by a doctor - keep away from eyes, lips, mouth and sensitive areas of the neckKeep 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
* Please review the disclaimer below.
