Label: SWEET BALM- peppermint oil stick

  • 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 May 2, 2022

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  • Active Ingredient

    Peppermint Oil 0.65%

  • Purpose

    nasal decongestion

  • Use

    Temporary relief of nasal congestion.

  • Warnings

    Do not use in or near the wounded areas.

  • Warnings

    When using this product do not use in or near the eyes.

  • Warnings

    Stop use and ask a doctor if irritation or rash appears and lasts.

  • Warnings

    Keep out of reach of children.

  • Warnings

    In case of contact, rinse eyes thoroughly with water.

  • Directions

    Adults and children 6 months and over.

    Apply to right below the nostrils.

    Allow to dry without wiping.

  • Inactive Ingredients

    Prunus AmygdalusDulcis (Sweet Almond) Oil, Butyrospermum Parkii (Shea) Butter, Beeswax, Eucalyptus Globulus Leaf Oil, Tocophery Acetate, Limonene, Linalool, Camellia Japonica Seed Oil, Cocos Nucifera (Coconut) Oil, Glyceryl Caprylate, Helianthus Annuus (Sunflower) Seed Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Macadamia Ternifolia Seed Oil, Prunus Armeniaca(Apricot) Kernel Oil, Moringa Oleifera Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Solanum Lycopersicum (Tomato) Seed Oil, Squalane, Vitis vinifera (Grape) seed oil, Chamaecyparis Obtusa Leaf Extract, Ginkgo Biloba Leaf Extract, Butylene Glycol, 1,2-Hexanediol

  • Sweet Balm Label

    Sweet Balm_Drug Facts Label

  • INGREDIENTS AND APPEARANCE
    SWEET BALM 
    peppermint oil stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82690-302
    Route of AdministrationTOPICAL, RESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL0.65 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CHAMAECYPARIS OBTUSA LEAF (UNII: 7OL154J5XB)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)  
    SQUALANE (UNII: GW89575KF9)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    GINKGO (UNII: 19FUJ2C58T)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TOMATO SEED OIL (UNII: 7N87T9C06T)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82690-302-014.3 g in 1 TUBE; Type 0: Not a Combination Product05/03/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35605/03/2022
    Labeler - isamogu Inc. (695695834)
    Registrant - isamogu Inc. (695695834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Isamogu Inc.695695834manufacture(82690-302)
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