OXY MAXIMUM ACTION SPOT TREATMENT- benzoyl peroxide cream 
The Mentholatum Company

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.

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Drug Facts

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.

Inactive Ingredients

anhydrous citric acid, butylene glycol, carbomer homopolymer, diazolidinyl urea, dimethicone, dimethyl isosorbide, edetate disodium, fragrance, glycerin, hydrolyzed soy protein, iodopropynyl butylcarbamate, lauryl methacrylate/glycol dimethacrylate crosspolymer, PEG/PPG-4/12 dimethicone, portulaca oleracea extract, propylene glycol, purified water, silica, sodium citrate, sodium hydroxide, xanthan gum

Package/Label Principal Display Panel

OXY Maximum Action Spot Treatment
OXY MAXIMUM ACTION SPOT TREATMENT 
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:10742-8301
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 
SOY PROTEIN 
IODOPROPYNYL BUTYLCARBAMATE 
LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER 
PEG/PPG-4/12 DIMETHICONE 
PURSLANE 
PROPYLENE GLYCOL 
WATER 
SILICON DIOXIDE 
SODIUM CITRATE 
SODIUM HYDROXIDE 
XANTHAN GUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10742-8301-11 in 1 CARTON
118.4 g in 1 TUBE
2NDC:10742-8301-24 g in 1 POUCH
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
Document Id: d694813f-be87-4519-af28-65a22df61623
Set id: d694813f-be87-4519-af28-65a22df61623
Version: 1
Effective Time: 20130108
 
The Mentholatum Company