Label: BARRIER CREAM- zinc oxide cream

  • NDC Code(s): 58518-040-02, 58518-040-03
  • Packager: Avasol LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 April 24, 2023

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

View All Sections
  • Active Ingredients

    Zinc Oxide (Non-nano) 10%

  • Purpose

    Skin protectant

  • Uses

    • Temporarily protects the skin and prevents chafing, blisters and irritation and helps seal out wetness.
    • Helps prevent and helps relieve minor skin irritation and itching due to rashes, chafed, chapped, cracked, or windburned skin.
  • Warnings

    • For external use only
    • Avoid contact with eyes. Rinse with water to remove.

    Stop use and ask a doctor

    • Condition worsens
    • symptoms last for more than 7 days or clear up and occur again within a few days

    Do not use:

    • if allergic to ingredients.
    • on deep or puncture wounds
    • on animal bites •on serious burns.
    • Test small area first.

    Keep out of reach of children.

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

  • Directions

    Apply liberally, directly on skin as needed. May be applied to prosthetics, protective equipment, etc. Will solidify at cold temps. Warm and knead as required.

  • Inactive ingredients

    *Caprylic/Capric Triglyceride (Fractionated Coconut Oil), *Cocos Nucifera (Coconut) Oil, *Cera Alba (beeswax), **Euphorbia Cerifera (candelilla) wax, *Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol, Olea Europaea (Olive) Leaf Extract, Citrus Aurantium Dulcis Peel Cera, Astaxanthin, Bentonite, Cetearyl Olivate, Sorbitan Olivate, *Propolis, *Lavandula Angustifolia (Lavender) Oil, *Rosmarinus Officinalis (Rosemary) Leaf Extract,*Aloe barbadensis,*St. John's wort (Hypericum perforatum),*Chamomile (Matricaria chamomilla L), *Licorice Root (Glycyrrhiza glabra), *Calendula Officinalis Flower Extract, **Leptospermum scoparium (Manuka) Oil, *Mentha Piperita (Peppermint) Oil *Organic **Wildcrafted

  • Other information

    Protect from freezing. Avoid excessive heat.

  • Questions?

    Call 888-805-1507 or visit www.avasol.com

  • Principal Display Panel - 59 mL Pouch Label

    avasol®

    BARRIER
    CREAM

    BIOBASED

    Multipurpose

    Anti-chafing

    Skin protectant

    No Petrochemicals • No Synthetics

    2 FL OZ (59 mL)

    Principal Display Panel - 59 mL Pouch Label
  • INGREDIENTS AND APPEARANCE
    BARRIER CREAM 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58518-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE100 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    ORANGE PEEL WAX (UNII: 0U715N387C)  
    ASTAXANTHIN (UNII: 8XPW32PR7I)  
    BENTONITE (UNII: A3N5ZCN45C)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    ROSEMARY (UNII: IJ67X351P9)  
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    ST. JOHN'S WORT (UNII: UFH8805FKA)  
    CHAMOMILE (UNII: FGL3685T2X)  
    LICORICE (UNII: 61ZBX54883)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    MANUKA OIL (UNII: M6QU9ZUH2X)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58518-040-0259 mL in 1 POUCH; Type 0: Not a Combination Product01/01/2022
    2NDC:58518-040-0328 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2022
    Labeler - Avasol LLC (078822898)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avasol LLC078822898MANUFACTURE(58518-040)
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!