Label: WINTER SKIN PROTECTANT- zinc oxide, allantoin ointment

  • Category: HUMAN OTC DRUG LABEL

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 June 2, 2022

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  • DRUG FACTS

  • Active Ingredients

    Zinc Oxide 20.00%

    Allantoin 2%

    Purpose

    Sunscreen

    Skin Protectant

  • Uses:

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

  • Warnings:

    For external use only.

    Do not use

    • on damaged or broken skin.
    • Do not use deep or puncture wounds animal bites serious burns.

    Stop use and ask a doctor 

    • If rash occurs conditions worsens symptoms last more than 7 days or clear up again within a few days.

    When using this product

    • Keep out of eyes.
    • Rinse with water to remove.

    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 of age: Ask a doctor.
  • Inactive Ingredients:

    Cocos Nucifera (Coconut) Oil, Cera Alba (Beeswax), Calendula Officinalis (Calendula Flower) Infused in Simmondsia Chinensis (Jojoba Oil), Tocopherol (Vitamin E)

  • Other Information:

    Protect this product from excessive heat and direct sun.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    WINTER SKIN PROTECTANT 
    zinc oxide, allantoin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82177-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION200 mg  in 1 mL
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82177-001-00120 mL in 1 JAR; Type 0: Not a Combination Product07/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/01/2022
    Labeler - Biomin LLC. (105075828)
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