Label: SCAR- 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 February 16, 2018

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  • Active ingredient                   Purpose

    Allantoin 0.5%........................Skin Protectant

  • PURPOSE

  • INDICATIONS & USAGE

    Uses temporarily protects and helps relieve chapped or cracked skin

  • WarningsFor external use only

  • WHEN USING

    When using this product • do not get into eyes

  • STOP USE

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

  • DO NOT USE

    Do not use on • deep puncture wounds • animal bites • serious burns

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed,get medical help or contact a Poison Control Center immediately

  • DOSAGE & ADMINISTRATION

    Directions • Apply as needed

  • INACTIVE INGREDIENT

    Inactive ingredients
    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.

  • OTHER SAFETY INFORMATION

    Other information Store at room temperature

  • QUESTIONS

    Questions? 1-888-287-1915

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    SCAR 
    allantoin 0.5% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-3131
    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
    ONION (UNII: 492225Q21H)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Sorbitol (UNII: 506T60A25R)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Oleic Acid (UNII: 2UMI9U37CP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ENGLISH WALNUT (UNII: 1V3SHR7QB7)  
    CHAMOMILE (UNII: FGL3685T2X)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    1,2-Hexanediol (UNII: TR046Y3K1G)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Phytonadione (UNII: A034SE7857)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-3131-011 in 1 CARTON03/14/2017
    120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/14/2017
    Labeler - Walgreens (008965063)
    Registrant - Product Quest Mdf (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mdf927768135manufacture(0363-3131) , label(0363-3131)
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