Label: EVEREDEN MULTI-PURPOSE HEALING BALM- glycerin jelly

  • 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 March 15, 2023

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  • STATEMENT OF IDENTITY

    Multi-Purpose Healing Balm

    Primary

  • ACTIVE INGREDIENT

    Glycerin 20%

  • PURPOSE

    Skin Protectant

  • USES

    • Temporarily protects and helps relieve chafed, chapped or cracked skin and lips.
    • Helps prevent and protect from the drying effects of wind and cold weather.

  • WARNINGS

    For external use only.
    • When using this 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

  • WARNINGS


    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    Apply as needed.
    • Children under 6 months: ask a doctor

  • INACTIVE INGREDIENTS

    Ricinus Communis (Castor) Seed Oil, Helianthus Annus (Sunflower) Seed Oil, Hydrogenated Castor Oil, Vitis Vinifera (Grape) Seed Oil, Rosa Canina (Rosehip) Seed Oil

  • PRINCIPAL DISPLAY PANEL

    Secondary

  • INGREDIENTS AND APPEARANCE
    EVEREDEN MULTI-PURPOSE HEALING BALM 
    glycerin jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72113-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    ROSA CANINA SEED (UNII: 4503R1M9UT)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72113-104-061 in 1 CARTON11/22/2021
    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 finalpart34611/22/2021
    Labeler - Eden Brands Inc (081062339)
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