Label: TEEVODAR- 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 May 4, 2023

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  • Active Ingredient

    Allantoin 0.5%

  • Purpose

    Skin Protectant

  • Uses

    Temporarily protects minor cuts scrapes burns

  • Warnings

    • For external use only
    • When using this product do not get into eyes
    • Stop use and ask a doctor if 
    • contition 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 a Poison Control Center right away.
  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    • Apply as needed. 
    • Children under 12 years of age: consult a doctor
  • Inactive Ingredients

    Ceteareth-20, Cetearyl alcohol, Cetyl alcohol, ethylhexylglycerin, Hamamelis virginiana (witch hazel) leaf extract, Isopropyl myristate, Lanolin, Mineral oil, Origanum vulgare (oregano) leaf extract, Petrolatum, Phenoxyethanol, Purified water, Rosmarinus officinalis (rosemary) leaf extract, Zea mayes (corn) oil

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    TEEVODAR 
    allantoin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69435-1301
    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
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    OREGANO (UNII: 0E5AT8T16U)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    ROSEMARY (UNII: IJ67X351P9)  
    CORN OIL (UNII: 8470G57WFM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69435-1301-11 in 1 CARTON05/15/2023
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/15/2023
    Labeler - PEER PHARM LTD. (514678390)
    Registrant - PEER PHARM LTD. (514678390)
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