Label: ANTI ITCH BALM- peppermint oil ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated March 29, 2013

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  • ACTIVE INGREDIENT

    Peppermint Oil* ---------- 0.34%

    *=Certified Organic Ingredient


  • PURPOSE

    Anti-Itch

  • INDICATIONS & USAGE

    Temporarily relieves itching associated with Insect bites, Eczema, Minor burn, Sunburn, Minor skin irritations, minor cuts, scrapes, atopic dermatitis.

  • ASK DOCTOR

    Ask a doctor if condition worsen

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • WARNINGS

    - For external use only

    - Do not use in or near the eyes

    - Keep out of reach of children

    - Ask a doctor if condition worsen

  • INSTRUCTIONS FOR USE

    - Apply affected area and rub rapidly for 10 seconds

    - Adults and children 2 years of age and older

    - Children under 2 years of age: ask a doctor

  • PRINCIPAL DISPLAY PANEL

    image of anti itch

  • DOSAGE & ADMINISTRATION

    Apply affected area and rub rapidly for 10 seconds.

  • INACTIVE INGREDIENT

    Simmondsiachinensis (Organic Jojoba oil)*,Helianthus annuus (Organic Sunflower oil)*,Butyrospermumparkii (Organic Shea butter)*,Cera alba (Organic Bees wax)*,Calophylluminophyllum (Organic Tamanu oil)*,Oenotherabiennis (Organic Evening primerose oil)*,Rosemarinusoficinalis (Organic Rosemary) extract*,Vitamin E Oil,Lavandulaangustifolia (Organic Lavender essential oil)*,Melaleucaalternifolia (Organic Tea tree essential oil)*,Matricariarecutita (Organic Chamomile blue essential oil)*,Anthemisnobilis (Organic Chamomile roman essential oil)*,Boswelliacarterii (Organic Frankincense essential oil)*,Achilleamillefolium (Organic Yarrow blue essential oil)*
    *= Certified Organic Ingredient

  • INGREDIENTS AND APPEARANCE
    ANTI ITCH BALM  
    peppermint oil ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57285-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Peppermint Oil (UNII: AV092KU4JH) (Peppermint - UNII:V95R5KMY2B) Peppermint Oil0.0952 g  in 28 g
    Inactive Ingredients
    Ingredient NameStrength
    JOJOBA OIL (UNII: 724GKU717M)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    TAMANU OIL (UNII: JT3LVK84A1)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
    FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57285-100-021 in 1 CARTON
    1NDC:57285-100-0128 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/29/2013
    Labeler - US ORGANIC GROUP CORP (078748578)
    Registrant - LEORARD MOON (078748578)
    Establishment
    NameAddressID/FEIBusiness Operations
    US ORGANIC GROUP CORP078748578manufacture(57285-100)
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