OXY 10  TINTED- benzoyl peroxide lotion 
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

Inactive Ingredients

carbomer homopolymer, diethylhexyl sodium sulfosuccinate, edetate disodium, iron oxide, purified water, sodium hydroxide, talc, titanium dioxide

Package/Label Principal Display Panel

Oxy 10 Tinted
OXY 10   TINTED
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8354
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10742-8354-11 in 1 CARTON07/01/2015
130 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D07/01/2015
Labeler - The Mentholatum Company (002105757)
Registrant - The Mentholatum Company (002105757)
Establishment
NameAddressID/FEIBusiness Operations
The Mentholatum Company002105757manufacture(10742-8354)

Revised: 2/2023
Document Id: f41fb0d6-aa81-95da-e053-2995a90a433e
Set id: 0ceee85d-dc8c-49b3-9b44-8fe60022c243
Version: 3
Effective Time: 20230207
 
The Mentholatum Company