Label: MEIJER SCAR GEL- allantoin 0.5% gel

  • 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 4, 2023

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  • ACTIVE INGREDIENT

    Allantoin 0.5%

  • PURPOSE

    Skin Protectant.

  • DOSAGE & ADMINISTRATION

    Temporarily protects and helps relieve chapped or cracked skin.

  • WARNINGS

    For external use only.

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if the condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

    Do not use on deep or puncture wounds, animal bites, and serious burns.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If the product is swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Apply as needed.

  • INACTIVE INGREDIENT

    Water, Glycerin, Glyceryl Acrylate/Acrylic Acid Copolymer, Propylene Glycol, Allium Cepa (Onion) Root Extract, Polysorbate 20, Sorbitol, Lecithin, Xanthan Gum, Oleic Acid, Beta-Glucan, Sodium Carbomer, Aloe Barbadensis Leaf Extract, Juglans Regia (Walnut) Seed Extract, Chamomilla Recutita (Matricaria) Flower Extract, Fragrance, Caprylyl Glycol, 1,2-Hexanediol, Ethylhexylglycerin, Phenoxyethanol, Disodium EDTA, Phytonadione.

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    MEIJER SCAR GEL 
    allantoin 0.5% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-1295
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    PHYTONADIONE (UNII: A034SE7857)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ONION (UNII: 492225Q21H)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ENGLISH WALNUT (UNII: 1V3SHR7QB7)  
    CHAMOMILE (UNII: FGL3685T2X)  
    SORBITOL (UNII: 506T60A25R)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79481-1295-119.8 g in 1 TUBE; Type 0: Not a Combination Product03/31/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/31/2021
    Labeler - Meijer (006959555)
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