OXY MAXIMUM ACTION ADVANCED FACE WASH- 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

wet face
apply to hands then work into a lather and massage gently onto face
rinse thoroughly and pat dry
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 usage 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

THIS PRODUCT MAY BLEACH HAIR OR DYED FABRICS
KEEP TIGHTLY CLOSED
avoid storing at temperatures above 100°F (38°C)

Inactive ingredients

anhydrous citric acid, butylene glycol, capryl/ capramidopropyl betaine, cetostearyl alcohol, cocamidopropyl betaine, diazolidinyl urea, disodium PEG-5 laurylcitrate sulfosuccinate, fragrance, hydrolyzed soy protein, hydroxyphenyl propamidobenzoic acid, methylparaben, PEG-8 dimethicone, pentylene glycol, propylparaben, purified water, sodium citrate, sodium lauroyl sarcosinate, xanthan gum

Questions?

1-877-636-2677 MON-FRI 9 AM-5 PM (EST)

Package/Label Principal Display Panel

Oxy Maximum Action Advanced Face Wash
OXY MAXIMUM ACTION ADVANCED FACE WASH 
benzoyl peroxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10742-8365
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 100 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYL/CAPRAMIDOPROPYL BETAINE (UNII: 231H3ZT9NE)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
SOY PROTEIN (UNII: R44IWB3RN5)  
HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:10742-8365-1 147.7 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333D 01/15/2013
Labeler - The Mentholatum Company (002105757)

Revised: 1/2013
Document Id: 03e0226b-ed02-4074-bc2f-f46db4e5a4a4
Set id: 03e0226b-ed02-4074-bc2f-f46db4e5a4a4
Version: 1
Effective Time: 20130121
 
The Mentholatum Company