Label: OXY SENSITIVE FACE WASH MAXIMUM SOOTHING- benzoyl peroxide lotion

  • NDC Code(s): 10742-1313-1, 10742-1313-2
  • Packager: The Mentholatum Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated November 15, 2019

If you are a consumer or patient please visit this version.

  • Active ingredient

    Benzoyl peroxide 5%

  • 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

    wet face
    apply to hands then work into a lather and massage gently onto face
    rinse thoroughly and pat dry
    because excessive drying of the skin may occur, start with 1 use daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor
    if bothersome dryness or peeling occurs, reduce application to once a day or every other day
    if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
    Sensitivity Test: Apply product sparingly to a small affected area for the first 3 days. If no discomfort occurs, follow directions above.
  • Other information

    THIS PRODUCT MAY BLEACH HAIR OR DYED FABRICS
    KEEP TIGHTLY CLOSED
    avoid storing at temperatures above 100°F (38°C)
  • Inactive ingredients

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

  • Questions?

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

  • Principal Display Panel

    Oxy Sensitive Skin
  • INGREDIENTS AND APPEARANCE
    OXY SENSITIVE FACE WASH  MAXIMUM SOOTHING
    benzoyl peroxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-1313
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE50 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)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    PURSLANE (UNII: M6S840WXG5)  
    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:10742-1313-1148 mL in 1 TUBE; Type 0: Not a Combination Product08/01/2016
    2NDC:10742-1313-2185 mL in 1 TUBE; Type 0: Not a Combination Product08/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D08/01/2016
    Labeler - The Mentholatum Company (002105757)