Label: IASOBETIC ALLANTOIN SKIN PROTECTANT- allantoin cream

  • 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 14, 2020

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  • Drug Facts

  • Active ingredient

    Allantoin 2%

    Purpose

    Skin Protectant

  • Use

    • temporarily protects minor:
    • cuts
    • scrapes
    • burns
    • helps prevent and temporarily protects chafed, chapped or cracked skin
  • Warnings

    For external use only

    When using this product

    • do not get into eyes.

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last 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 Poison Control Center right away.

  • Directions

    apply as needed

  • Other information

    Store at room temperature 15-27° C (59-80° F)

  • Inactive ingredients

    Aloe vera leaf juice, shea butter, turmeric, coconut oil, carbomer, cetyl alcohol, dimethicone, diatomite, glucosamine, glycol stearate SE, EDTA disodium, ethylhexylglycerin, glycerin, isopropyl myristate, laureth-8, lecithin, gotu kola, stearic acid, plantain leaf extract powder, phenoxyethanol, hydrogenated polydecene, purified water, pullulan, sodium acrylate/sodium acryloyldimethyl taurate copolymer, sclerotium gum, triethanolamine, xanthan gum.

  • Package Labeling:

    Outer LabelInner Label

  • INGREDIENTS AND APPEARANCE
    IASOBETIC ALLANTOIN SKIN PROTECTANT 
    allantoin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72904-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    TURMERIC (UNII: 856YO1Z64F)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)  
    GLUCOSAMINE (UNII: N08U5BOQ1K)  
    GLYCOL STEARATE SE (UNII: 6YLY96TQL6)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LAURETH-8 (UNII: QU7U88D04I)  
    CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72904-001-501 in 1 BOX03/01/2020
    150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/01/2020
    Labeler - IASOBETIC WOUND CARE CORP. (115173710)
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