Label: SKIN RESCUE SET- 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 May 28, 2021

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  • Active Ingredient

    Salicylic Acid 0.5%

    Purpose

    Acne Treatment

  • Uses

    For the treatment of acne

  • Warnings

    For external use only.

    When using this product

    • Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
    • Avoid contact with eyes.

    Stop use and ask a doctor if

    • irritation or redness develops and persists.

    Do not use

    • On irritated or sunburnt skin.

    Keep out of reach of children.
    • If ingested get medical help or contact a Poison Control Center right away.
  • Directions

    Sensitiviy test for new user

    • Prior to first use, conduct a 24-hour patch test on a small area of your arm on clean, dry skin to determine skin reactivity.
    • Proceed with normal usage only if irritation does not occur, as directed below.
    • Cleanse face with soap and warm water to remove all traces of make-up, oil and dirt.
    • Select a dot-shaped patch that is larger than the acne blemish and adhere the patch over the area to be treated. 
    • After 8 hoiurs remove by gently peeling back and discarding.
    • Cleanse the treated area and apply another patch if desired.
  • Other information

    • Store in a cool dry place, use immediately after removing from the sheet.
  • Inactive ingredients

    Cellulose Gum, Ethylene/VA Copolymer, Polyisobutene, Xanthan Gum, Aloe Barbadensis Leaf Extract, Melaleuca Alternifolia (Tea Tree) Oil, Propylene Glycol, Retinol.

  • Questions?

    Call 1-800-548-4097

  • Label copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    SKIN RESCUE SET 
    salicylic acid patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78936-024
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    ETHYLENE-VINYL ACETATE COPOLYMER (9% VINYLACETATE) (UNII: 4OKC630HS6)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    RETINOL (UNII: G2SH0XKK91)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78936-024-0136 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product05/27/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D05/27/2021
    Labeler - Hangzhou Caring Cleaning Commodity Co., LTD (413905445)
    Registrant - Hangzhou Caring Cleaning Commodity Co., LTD (413905445)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hangzhou Caring Cleaning Commodity Co., LTD413905445manufacture(78936-024)
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