Label: FIRST HONEY BURN SALVE- allantoin cream

  • NDC Code(s): 81995-056-01, 81995-056-02
  • Packager: First Honey, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 10, 2023

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  • Drug Facts

  • Active ingredient

    Allantoin 0.5%

    Purpose

    Skin Protectant

  • Uses

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

    For external use only

    When using product

    • do not get into eyes

    Stop use and ask a doctor if

    • Conditions worsen
    • Symptoms last more than 7 days or clear up and occur again within a few days

    Do not use on

    • Deep or puncture
    • wounds
    • Animal bites
    • Serious burns

    Keep out of reach of children.

    If swallowed, get medical help, or contact a Poison Control Center right away.

  • Directions

    • Apply as needed
  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, Anthemis Nobilis Flower Oil, Argania Spinosa Kernel Oil, Benzyl Alcohol, Caprylic/Capric Triglyceride, Cucumis Sativus Fruit Extract, Ethylhexylglycerin, Helianthus Annuus Extract, Lavandula Angustifolia Oil, Lecithin, Manuka Honey, Mixed Tocopherols, Oryza Sativa Bran Extract, Propanediol, Rosa Canina Seed Oil, Rosmarinus Officinalis Leaf Extract, Sodium Acrylates Copolymer, Soya Bean Oil, Tetrahexyldecyl Ascorbate, Tocopherol, Water (Aqua).

  • Questions or comments?

    1-615-212-8585

  • Package Labeling:

    Outer LabelInner Label

  • Package Labeling: 81995-056-02

    5mL label

  • INGREDIENTS AND APPEARANCE
    FIRST HONEY BURN SALVE 
    allantoin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81995-056
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    HONEY (UNII: Y9H1V576FH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ROSA CANINA SEED OIL (UNII: MHT97MG5P8)  
    ROSEMARY (UNII: IJ67X351P9)  
    HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81995-056-011 in 1 CARTON05/10/2022
    1100 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:81995-056-021 in 1 CARTON06/01/2023
    25 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01605/10/2022
    Labeler - First Honey, LLC (080994597)
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