Label: SHIELD AND HEAL LIP BALM- menthol kit

  • 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

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

  • Product Packaging

    4 pack

  • INGREDIENTS AND APPEARANCE
    SHIELD AND HEAL LIP BALM 
    menthol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81470-002
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81470-002-011 in 1 KIT; Type 0: Not a Combination Product02/15/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 4.25 g
    Part 21 TUBE 4.25 g
    Part 1 of 2
    SHIELD AND HEAL MEDICATED LIP BALM 
    menthol stick
    Product Information
    Item 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
    SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)  
    OATMEAL (UNII: 8PI54V663Y)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    KARUM SEED OIL (UNII: 62160PU6FJ)  
    GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    LANOLIN (UNII: 7EV65EAW6H)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)  
    HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)  
    JOJOBA OIL (UNII: 724GKU717M)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12 in 1 KIT
    14.25 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
    Part 2 of 2
    SHIELD AND HEAL BOTANICAL LIP BALM 
    lipstick stick
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRSYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
    INGRCARNAUBA WAX (UNII: R12CBM0EIZ)  
    INGRSHEA BUTTER (UNII: K49155WL9Y)  
    INGRBUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)  
    INGRORANGE OIL (UNII: AKN3KSD11B)  
    INGRCOCONUT OIL (UNII: Q9L0O73W7L)  
    INGRKARUM SEED OIL (UNII: 62160PU6FJ)  
    INGRGARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)  
    INGRLAVENDER OIL (UNII: ZBP1YXW0H8)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRCASTOR OIL (UNII: D5340Y2I9G)  
    INGRGLYCERYL LAURATE (UNII: Y98611C087)  
    INGRSUNFLOWER OIL (UNII: 3W1JG795YI)  
    INGRLANOLIN (UNII: 7EV65EAW6H)  
    INGREUCALYPTUS OIL (UNII: 2R04ONI662)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRCANDELILLA WAX (UNII: WL0328HX19)  
    INGRACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)  
    INGRHIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)  
    INGRJOJOBA OIL (UNII: 724GKU717M)  
    INGRPROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12 in 1 KIT
    14.25 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic02/15/2021
    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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