Label: MANUKA HONEY EXTRA STRENGTH- allantoin gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 6, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • 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

    Do not use

    • In the eyes
    • On deep or puncture wounds
    • Animal bites
    • Serious burns

    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

    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

    Helianthus Annuus Extract, Lecithin, Mãnuka Honey, Oryza Sativa Bran Extract, Propanediol, Potassium Sorbate, Rosmarinus Officinalis Leaf Extract, Sodium Acrylates Copolymer, Sodium Benzoate, Tetrasodium Glutamate Diacetate, Tocopherol, Water (Aqua).

  • Questions?

    1-615-488-8168

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    MANUKA HONEY EXTRA STRENGTH 
    allantoin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81995-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPANEDIOL (UNII: 5965N8W85T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ROSEMARY (UNII: IJ67X351P9)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81995-050-011 in 1 CARTON09/01/2024
    121 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01609/01/2024
    Labeler - First Honey LLC (080994597)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!