Label: DEFLAME- allantoin cream

  • NDC Code(s): 78863-1270-1
  • Packager: Noon Aesthetics M.R. Ltd
  • 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 September 15, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Allantoin 0.5%

  • Purpose

    Skin Protectant

  • Uses

    • Temporarily protects minor: skin irritation, cuts, scrapes, burns and helps protect and relieve chafed, chapped or cracked skin.
  • Warnings

    For external use only.

    Do not use on

    • deep or puncture wounds, animal bites, serious burns.

    When using this product

    • avoid contact with eyes. In case of eye contact, flush with water.

    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.

  • Directions

    • Apply as needed.
  • Inactive Ingredients

    Aqua, Propylene Glycol, Glycerin, Dimethyl Sulfone, Strontium Chloride Hexahydrate, Polydimethylsiloxane, Cetyl Alcohol, Glyceryl Stearate, Propanediol, Dipotassium Glycyrrhizate, Polysorbate 20, PEG-40 Stearate, Laureth-4, Porphyridium Polysaccharide, Arnica Montana Flower Extract, sh-Oligopeptide-1 (EGF), sh-Oligopeptide-2 (IGF-1), sh-Polypeptide-1 (bFGF), sh-Polypeptide-9 (VEGF), sh-Polypeptide-11 (FGF-1), Bacillus/Folic Acid Ferment Filtrate Extract, Octyldodecyl Xyloside, Butylene Glycol, Sodium Hyaluronate, 1,2-Hexanediol, Acetyl Glutamine, Octyldodecanol, PEG-30 Dipolyhydroxystearate, Sorbitan Tristearate, Lecithin, Phenoxyethanol, Benzyl Alcohol, Caprylyl Glycol, Potassium Sorbate, Disodium EDTA, Sodium Benzoate.

  • Questions or comments?

    Visit noonaesthetics.com or call Toll Free 1.833.666.6246

  • SPL UNCLASSIFIED SECTION

    Dist by NOON Aesthetics
    TLV, 62153

  • PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton

    noon
    AESTHETICS

    DeFlame
    SKIN PROTECTANT

    + DERMSHIELD™

    50 ml / 1.75 Fl. Oz. e

    Principal Display Panel - 50 ml Tube Carton
  • INGREDIENTS AND APPEARANCE
    DEFLAME 
    allantoin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78863-1270
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    STRONTIUM CHLORIDE HEXAHYDRATE (UNII: O09USB7Z44)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    LAURETH-4 (UNII: 6HQ855798J)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    OCTYLDODECYL XYLOSIDE (UNII: 8Z6VNR46QM)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    ACEGLUTAMIDE (UNII: 01J18G9G97)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
    SORBITAN TRISTEARATE (UNII: 6LUM696811)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78863-1270-11 in 1 CARTON10/01/2023
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35210/01/2023
    Labeler - Noon Aesthetics M.R. Ltd (600185560)
    Establishment
    NameAddressID/FEIBusiness Operations
    Noon Aesthetics M.R. Ltd600185560MANUFACTURE(78863-1270)
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