Label: M SKIN CARE BLEMISH PATCHES- salicylic acid 0.5% patch

  • NDC Code(s): 71420-102-09
  • Packager: Sales and Product Solutions
  • 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 March 10, 2023

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

  • ACTIVE INGREDIENT

    Salicylic Acid 0.5%

  • PURPOSE

    Acne Treatment

  • INDICATIONS & USAGE

    For the treatment of acne

    Clears up acne blemishes, blackheads and allows skin to heal.

  • WARNINGS

    For External Use Only.

  • 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.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Before application, thoroughly clean and dry affected area.
    Apply an appropriately sized patch to blemish
    Pat edges of patch to secure and contain blemish.
    Leave in place for at least 8 hours or overnight to permit healing
    To remove, gently peel back patch and discard.
    Cleanse affected area and repeat application with a fresh blemish patch, if desired.
    Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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 INGREDIENT

    Acrylates Copolymer,Vinyl Caprolactam/VP/Dimethylaminoethyl Methacrylate Copolymer, water, Alcohol Denat. Butylene Glycol, Melaleuca Alternifolia (Tea Tree) Leaf Oil,PVP, Salicylic Acid, Phenoxyethanol, Polysorbate 80, Epilobium Angustifolium Flower/Leaf/Stem Extract, Vitis Vinifera (Grape) Seed Extract, Sodium Metabisulfite, Volcanic Ash, Alcohol, Phytosphingosine, Sodium Hyaluronate.

  • M Skin Care Blemish Patches

    label

  • INGREDIENTS AND APPEARANCE
    M SKIN CARE BLEMISH PATCHES 
    salicylic acid 0.5% patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71420-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    STREPTOCOCCUS PYOGENES (UNII: LJ2LP0YL98)  
    ALCOHOL (UNII: 3K9958V90M)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    2-PROPENOIC ACID, 2-(PHOSPHONOOXY)- (UNII: 545YL308OW)  
    PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    EPILOBIUM ANGUSTIFOLIUM LEAF (UNII: 7NV86426N2)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71420-102-091 in 1 POUCH; Type 0: Not a Combination Product07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/01/2020
    Labeler - Sales and Product Solutions (037519852)