Label: HEALING CVS- 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 December 8, 2017

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  • Active ingredient                            Purpose

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

  • PURPOSE

  • Uses

     temporarily protects and helps relieve chapped or cracked skin

  • Warning

    For external use only.
    Do not use on • deep puncture wounds• animal bites • serious burns

    When using this product • do not get into eyes

    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

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

  • DOSAGE & ADMINISTRATION

    Directions • Apply as needed

  • OTHER SAFETY INFORMATION

    Other information Store at room temperature

  • Inactive ingredients

    Water, Glycerin, Avena Sativa (Oat) Kernel Extract, Aloe Barbadensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Propylene Glycol, Beta-Glucan, 1,2-Hexanediol, Caprylyl Glycol, Glyceryl Acrylate/Acrylic Acid Copolymer, Sorbitol, Lecithin, Xanthan Gum, Oleic  Acid, Iron Oxide, Sodium Carbomer, Disodium EDTA, Phenoxyethanol, Ethylhexylglycerin

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    HEALING  CVS
    allantoin - 0.5% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-436
    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
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    OAT (UNII: Z6J799EAJK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHAMOMILE (UNII: FGL3685T2X)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    CURDLAN (UNII: 6930DL209R)  
    1,2-Hexanediol (UNII: TR046Y3K1G)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Sorbitol (UNII: 506T60A25R)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Oleic Acid (UNII: 2UMI9U37CP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-436-04113 g in 1 JAR; Type 0: Not a Combination Product11/30/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34711/30/2015
    Labeler - CVS (062312574)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(59779-436) , label(59779-436)
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