OXY RAPID SPOT TREATMENT  MAXIMUM ACTION- 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

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 Rapid Spot Treatment
OXY RAPID SPOT TREATMENT   MAXIMUM ACTION
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-1301
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
SOY PROTEIN (UNII: R44IWB3RN5)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EX0F4CZ66H)  
PEG/PPG-4/12 DIMETHICONE (UNII: JAN3585W85)  
PURSLANE (UNII: M6S840WXG5)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10742-1301-11 in 1 CARTON01/01/2015
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/01/2015
Labeler - The Mentholatum Company (002105757)
Registrant - The Mentholatum Company (002105757)
Establishment
NameAddressID/FEIBusiness Operations
The Mentholatum Company002105757manufacture(10742-1301)

Revised: 2/2023
Document Id: f41f5df4-2827-35d3-e053-2995a90adcf4
Set id: 226dad56-e415-41ec-937a-4282c73f0d34
Version: 3
Effective Time: 20230207
 
The Mentholatum Company