Label: MISS SPA BANISH MICRONEEDLE SPOT TREATMENT- salicylic acid 0.5% 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 December 2, 2021

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  • Active Ingredient

    Salicylic Acid 0.5%

  • Purpose

    Acne Treatment

  • Use

    For the Treatment of Acne
    Clears up Acne blemish, 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.

  • Directions

    • Before applying patches, thoroughly cleanse and dry the affected area
    • Apply patch and press down for 15 seconds, patting the edges of patch to secure and contain the blemish.
    • Leave the patch in place for at least 6 hours or overnight to permit healing
    • To remove, gently peel back and discard
    • Cleanse affected area and repeat application with a fresh blemish patch, if desired.
  • Inactive Ingredients

    Sodium Hyaluronate, Trehalose, Propanediol, Caprylyl Glycol, Madecassoside, Dipotassium Glycyrrhizate, Ethylhexylglycerin

  • Miss Spa Banish Microneedle Spot Treatment

    label

  • INGREDIENTS AND APPEARANCE
    MISS SPA BANISH MICRONEEDLE SPOT TREATMENT 
    salicylic acid 0.5% patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37520-006
    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
    TREHALOSE (UNII: B8WCK70T7I)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    MADECASSOSIDE (UNII: CQ2F5O6YIY)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37520-006-066 g in 1 PACKET; Type 0: Not a Combination Product01/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/01/2021
    Labeler - SALES AND PRODUCT SOLUTIONS (037519852)
    Registrant - SALES AND PRODUCT SOLUTIONS (037519852)
    Establishment
    NameAddressID/FEIBusiness Operations
    Small Lab Co., Ltd.688438425manufacture(37520-006)
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