Label: SALICYLIC ACID PIMPLE PATCHES- acne patches with salicylic acid patch

  • 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 January 17, 2023

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  • Active Ingredient

    Salicylic Acid 0.5%

  • Purpose

    Acne Treatment

  • Use

    for the management of acne.

  • 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.

  • Directions

    • Clean skin thoroughly before applying this product
    • Apply product directly to the affected area.
    • Leave on for 6 hours or overnight then remove.
    • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • Other Information

    • Store in a cool, dry place
  • Inactive Ingredients

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

  • How to use:

    Step 1

    Prepare the area by cleansing Skin

    Step 2

    Apply patch to blemish

    Step 3

    Leave for 6+ hours or overnight

    Step 4

    Remove patch. Repeat if necessary.

  • Questions or comments?

    Distributed by Skin PS Brands

    Culver City, CA 90232

    Made in Korea

    www.slmdskincare.com

  • SLMD Sandra Lee MD

    Real results for everybody.

    Created by Dr. Pimple Popper

    SLMD

    Salicylic Acid Pimple Patches

    Acne Treatment

    Formulated with salicylic acid to gently exfoliate, help soothe irritation and provide pore-purifying benefits. Each patch absorbs excess oil and pus, while providing an occlusive barrier to stop the spread of acne-causing bacteria.

    24 Ultra-Thin, Invisible Patches

    Includes 12 small & 12 large sizes

    Pimple Patch Envelope:

    EnvelopePimple Patch Sachet:

    Sachet

  • INGREDIENTS AND APPEARANCE
    SALICYLIC ACID PIMPLE PATCHES 
    acne patches with salicylic acid patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73318-1040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    KAOLIN (UNII: 24H4NWX5CO)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    ACRYLIC ACID/DIMETHICONE METHACRYLATE/ETHYLHEXYL ACRYLATE COPOLYMER (UNII: E5024Y9FFQ)  
    ALCOHOL (UNII: 3K9958V90M)  
    DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EPILOBIUM ANGUSTIFOLIUM WHOLE (UNII: C278QS9YBT)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    POVIDONE K30 (UNII: U725QWY32X)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73318-1040-41 in 1 CARTON01/17/2023
    124 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/17/2023
    Labeler - Skin PS Brands (081085221)
    Registrant - Skin PS Brands (081085221)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taiki688783559manufacture(73318-1040)
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