OXY 10 ACNE CLEANSER- benzoyl peroxide cream 
The Mentholatum Company

----------

Drug Facts - OXY 10 Acne Cleanser

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

Other information

Inactive ingredients

water, cetostearyl alcohol, sodium C14-16 olefin sulfonate, disodium laureth sulfosuccinate, capryl/capramidopropyl betaine, xanthan gum, butylene glycol, citric acid, diazolidinyl urea, fragrance, hydrolyzed soy protein, hydroxyphenyl propamidobenzoic acid, methylparaben, PEG-8 dimethicone, pentylene glycol, propylparaben, sodium citrate, sodium hydroxide, sodium lauroyl sarcosinate

Questions?

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

Package/Label Principal Display Panel

Oxy 10 Acne Cleanser
OXY 10 ACNE CLEANSER 
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-1397
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
CAPRYL/CAPRAMIDOPROPYL BETAINE (UNII: 231H3ZT9NE)  
XANTHAN GUM (UNII: TTV12P4NEE)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
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)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10742-1397-1148 mL in 1 TUBE; Type 0: Not a Combination Product07/01/2018
2NDC:10742-1397-2185 mL in 1 TUBE; Type 0: Not a Combination Product07/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00607/01/2018
Labeler - The Mentholatum Company (002105757)
Registrant - The Mentholatum Company (002105757)
Establishment
NameAddressID/FEIBusiness Operations
The Mentholatum Company002105757manufacture(10742-1397)

Revised: 12/2024
Document Id: 292c66f4-62e2-d3cf-e063-6394a90a6fdb
Set id: 35dbfe37-992d-4c9c-a4be-707d32370c76
Version: 6
Effective Time: 20241213
 
The Mentholatum Company