Label: SHIELD AND HEAL MEDICATED LIP BALM- menthol stick

  • NDC Code(s): 81470-001-01, 81470-001-02
  • Packager: Shield and Heal Inc.
  • 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 27, 2023

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  • Drug Facts

  • Active ingredient

    Menthol 1%

  • Purpose

    External analgesic

  • Use

    for the temporary relief of pain and itching associated with fever blisters and cold sores.

  • Warnings

    For external use only.

    If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

    When using this product

    avoid contact with eyes.

    Keep out of reach of children.

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

  • Directions

    • adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
    • children under 2 years of age: consult a doctor.
  • Other information

    • Store at room temperature and avoid excessive heat.
  • Inactive ingredients

    Helianthus Annuus (Sunflower) Seed Oil, Moringa Oil/Hydrogenated Moringa Oil Esters, Synthetic Beeswax, Euphorbia Cerifera (Candelilla) Wax, Copernicia Cerifera Cera, Ricinus Communis (Castor) Seed Oil, Lanolin, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Butyrospermum Parkii (Shea) Butter Unsaponifiables, Camphor, Avena Sativa (Oat) Kernel Flour, Butyrospermum Parkii (Shea Butter), Citrus Aurantium Dulcis (Orange) Peel Oil, Cocos Nucifera (Coconut) Oil, Eucalyptus Globulus Leaf Oil, Garcinia Indica Seed Butter, Glyceryl Laurate, Hippophae Rhamnoides (Sea Buckthorn) Fruit Oil, Lavandula Angustifolia (Lavender) Oil, Pongamia Glabra Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Propolis Extract, Water, Achillea Millefolium Flower Extract.

  • QUESTIONS

    Call toll free 888-933-3253 or learn more at www.shieldandheal.com

  • Product Packaging

    1 pack

  • INGREDIENTS AND APPEARANCE
    SHIELD AND HEAL MEDICATED LIP BALM 
    menthol stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81470-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL LAURATE (UNII: Y98611C087)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    JOJOBA OIL (UNII: 724GKU717M)  
    ACHILLEA MILLEFOLIUM WHOLE (UNII: 2FXJ6SW4PK)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    WATER (UNII: 059QF0KO0R)  
    GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    KARUM SEED OIL (UNII: 62160PU6FJ)  
    OATMEAL (UNII: 8PI54V663Y)  
    LANOLIN (UNII: 7EV65EAW6H)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81470-001-011 in 1 CARTON02/15/2021
    14.25 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:81470-001-022 in 1 CARTON02/15/2021
    24.25 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/15/2021
    Labeler - Shield and Heal Inc. (117700988)
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