OXY ADVANCED CARE RAPID SPOT TREATMENT- benzoyl peroxide gel 
The Mentholatum Company

----------

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

Image 1

OXY  ADVANCED CARE RAPID SPOT TREATMENT
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-1201
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:10742-1201-11 in 1 CARTON07/12/2021
128 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:10742-1201-21 in 1 CARTON12/01/2021
232.6 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:10742-1201-31 in 1 CARTON02/21/2022
318.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00607/12/2021
Labeler - The Mentholatum Company (002105757)

Revised: 2/2024
Document Id: 10ba9022-0dd4-c6f2-e063-6294a90a30a4
Set id: 0a608bd9-029a-4194-9173-acdcc32056b7
Version: 5
Effective Time: 20240206
 
The Mentholatum Company