Label: SCAR GEL- scar cream gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 August 24, 2022

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  • Active Ingredient(s)

    Allantoin 0.3%

  • Purpose

    Skin Protectant

  • Use

    Temporarily protects and helps relieve chapped or cracked skin.

  • Warnings

    For external use only.

  • Do not use

    /

  • WHEN USING

    do not get into eyes.

  • STOP USE

    condition worsens symptoms last more than 7daysor clear up and occur again within a few days DO not use on.
    deep or puncture wounds animal bites serious burns.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    condition worsens symptoms last more than 7daysor clear up and occur again within a few days DO not use on.

  • Other information

    /

  • Inactive ingredients

    CYCLOPENTASILOXANE
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER

    HEXYLDECANOL
    STEARIC ACID
    BRASSICA CAMPESTRIS (RAPESEED) STEROLS
    ARGANIA SPINOSA KERNEL OIL
    TOCOPHERYL ACETATE
    CERAMIDE 3
    CERAMIDE 6 II
    CHOLESTEROL
    MADECASSOSIDE

  • Package Label - Principal Display Panel

    75728-004-01 15 g in 1 BOTTLE

    75728-004-01 15 g in 1 BOTTLE

    75728-004-02 20 g in 1 BOTTLE

    75728-004-02 20 g in 1 BOTTLE

    75728-004-03 30 g in 1 BOTTLE

    75728-004-03 30 g in 1 BOTTLE

  • INGREDIENTS AND APPEARANCE
    SCAR GEL 
    scar cream gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75728-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    HEXYLDECANOL (UNII: 151Z7P1317)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    RAPESEED STEROL (UNII: B46B6DD20U)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    CERAMIDE 6 II (UNII: F1X8L2B00J)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    MADECASSOSIDE (UNII: CQ2F5O6YIY)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75728-004-0115 g in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:75728-004-0330 g in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    3NDC:75728-004-0220 g in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/30/2020
    Labeler - Guangzhou Meayon Biotechnology Co,.Ltd (554520941)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Meayon Biotechnology Co,.Ltd554520941manufacture(75728-004)
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