Label: OXY OVERNIGHT ACNE REDUCING PATCHES- salicylic acid patch

  • NDC Code(s): 10742-8177-1
  • 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 February 7, 2023

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  • Active ingredient

    Salicylic acid 0.5%

  • Purpose

    Salicylic acid - Acne treatment

  • Uses

    treats and helps prevent acne

  • Warnings

    For external use only

    When using this product

    • keep away from eyes, lips and mouth. If contact occurs, flush thoroughly with water.
    • 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.

    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

    • cleanse skin thoroughly before applying this product
    • apply patch(es) to affected area(s)
    • to remove, gently peel back patch and discard
    • because excessive drying of the skin may occur, start with 1 application 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
  • Inactive ingredients

    acrylates/ethylhexyl acrylate copolymer, water, nonoxynol-30, alcohol denatured, butylene glycol, C13-14 isoparaffin, epilobium angustifolium flower/leaf/stem extract, kaolin, laureth-7, melaleuca alternifolia (tea tree) leaf oil, phenoxyethanol, phytosphingosine, polysorbate 80, PVP, sodium hyaluronate, sodium hydroxide, sodium metabisulfite, sodium polyacrylate, vitis vinifera (grape) seed extract, volcanic ash

  • Questions?

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

  • Principal Display Panel

    Oxy Overnight Acne Reducing Patches
  • Principal Display Panel

    Drug Facts
  • INGREDIENTS AND APPEARANCE
    OXY OVERNIGHT ACNE REDUCING PATCHES 
    salicylic acid patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8177
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg
    Inactive Ingredients
    Ingredient NameStrength
    2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
    WATER (UNII: 059QF0KO0R)  
    NONOXYNOL-30 (UNII: JJX07DG188)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    EPILOBIUM ANGUSTIFOLIUM WHOLE (UNII: C278QS9YBT)  
    KAOLIN (UNII: 24H4NWX5CO)  
    LAURETH-7 (UNII: Z95S6G8201)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-8177-130 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/01/2018
    Labeler - The Mentholatum Company (002105757)
    Registrant - The Mentholatum Company (002105757)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Mentholatum Company002105757manufacture(10742-8177)
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