OXY  ADVANCED CARE RAPID SPOT TREATMENT- benzoyl peroxide gel 
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

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 the 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 Safety Information

  • avoid storing at temperatures above 100 OF (38 OC)

Inactive Ingredients

water, glycerin, butylene glycol, carbomer, chlorphenesin, citric acid, dimethyl isosorbide, disodium EDTA, fragrance, hydrated silica, hydrolyzed soy protein, lauryl methacrylate/glycol dimethacrylate crosspolymer, PEG/PPG-4/12 dimethicone, phenoxyethanol, portulaca oleracea extract, propanediol, rhodomyrtus tomentosa fruit extract, sodium citrate, sodium hydroxide, xanthan gum

Questions

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

Package/Label Principal Display Panel

Sachet
OXY   ADVANCED CARE RAPID SPOT TREATMENT
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-1205
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
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SOY PROTEIN (UNII: R44IWB3RN5)  
LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EX0F4CZ66H)  
PEG/PPG-4/12 DIMETHICONE (UNII: JAN3585W85)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PURSLANE (UNII: M6S840WXG5)  
PROPANEDIOL (UNII: 5965N8W85T)  
RHODOMYRTUS TOMENTOSA FRUIT (UNII: Q99511S58K)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10742-1205-12 g in 1 POUCH; Type 0: Not a Combination Product03/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D03/31/2022
Labeler - The Mentholatum Company (002105757)

Revised: 4/2023
Document Id: f94d7fda-d1ae-406b-e053-6294a90a1b98
Set id: e613e8a6-ffed-49bc-bdc0-87606c51ffa3
Version: 2
Effective Time: 20230414
 
The Mentholatum Company