Your browser does not support JavaScript! OXY MAXIMUM ACTION SPOT TREATMENT TINTED (BENZOYL PEROXIDE) CREAM [THE MENTHOLATUM COMPANY]
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OXY MAXIMUM ACTION SPOT TREATMENT TINTED (benzoyl peroxide) cream
[The Mentholatum Company]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Sections

Active ingredient

Benzoyl peroxide 10%

Purpose

Acne treatment

Uses

treats and helps prevent acne

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 this 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

clean skin thoroughly before applying this product
cover entire affected area with a thin layer 1 to 3 times daily
because excessive drying of the skin may occur, start with 1 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 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 and ask a doctor.

Other information

avoid storing at temperatures above 100°F (38°C)

Inactive ingredients

anhydrous citric acid, butylene glycol, carbomer homopolymer, diazolidinyl urea, dimethicone, dimethyl isosorbide, edetate disodium, fragrance, glycerin, iodopropynyl butylcarbamate, iron oxides, lauryl methacrylate/glycol dimethacrylate crosspolymer, PEG-8 methyl ether triethoxysilane, PEG/PPG-4/12 dimethicone, portulaca oleracea extract, propylene glycol, purified water, silica, sodium citrate, sodium hydroxide, talc, titanium dioxide, xanthan gum

Questions?

Toll free 1-877-636-2677

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Package/Label Principal Display Panel

OXY Maximum Action Tinted Spot Treatment
OXY MAXIMUM ACTION SPOT TREATMENT  TINTED
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:10742-8302
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
BUTYLENE GLYCOL 
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
DIAZOLIDINYL UREA 
DIMETHICONE 
DIMETHYL ISOSORBIDE 
EDETATE DISODIUM 
GLYCERIN 
IODOPROPYNYL BUTYLCARBAMATE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER 
PEG/PPG-4/12 DIMETHICONE 
PURSLANE 
PROPYLENE GLYCOL 
WATER 
SILICON DIOXIDE 
SODIUM CITRATE 
SODIUM HYDROXIDE 
TALC 
TITANIUM DIOXIDE 
XANTHAN GUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10742-8302-11 in 1 CARTON
118.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333D01/15/2013
Labeler - The Mentholatum Company (002105757)

Revised: 1/2013
 
The Mentholatum Company

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