Active Ingredient
Benzoyl peroxide 10%
Oxy Maximum Strength Acne Cream Cleanser Cream
FDA Label NDC 10742-1003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Mentholatum Company for the product Oxy Maximum Strength Acne Cream Cleanser (NDC 10742-1003). 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 active ingredient, purpose, uses, warnings, do not use if you, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Acne treatment
Uses
- for the treatment of acne
- clears acne pimples and allows skin to heal
- penetrates pores to control blackheads and whiteheads
- helps prevent new acne pimples from forming
Warnings
For external use only
Do Not Use If You
- have very sensitive skin
- 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.
- 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
irritation becomes severe
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- wet face
- apply to hands then massage gently into face. If desired, leave on for 1-2 minutes.
- rinse thoroughly and pat dry
- follow with a non-comedogenic moisturizer if needed
- because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times
- if bothersome dryness or peeling occurs, reduce application to once a day or every other day
- if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products
daily if needed or as directed by a doctor
and ask a doctor.
Other Information
- THIS PRODUCT MAY BLEACH HAIR OR DYED FABRICS
- KEEP TIGHTLY CLOSED
- avoid storing at temperatures above 100°F (38°C)
Inactive Ingredients
water, cetostearyl alcohol, sodium C14-16 olefin sulfonate, disodium laureth sulfosuccinate, capryl/capramidopropyl betaine, xanthan gum, butylene glycol, chlorphenesin, citric acid, fragrance, glycerin, hydrolyzed soy protein, hydroxyphenyl propamidobenzoic acid, PEG-8 dimethicone, pentylene glycol, phenoxyethanol, propanediol, rhodomyrtus tomentosa fruit extract, sodium citrate, sodium hydroxide, sodium lauroyl sarcosinate
Questions?
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