Label: ANTI ITCH BALM - peppermint oil ointment

  • NDC Code(s): 57285-100-01, 57285-100-02
  • Packager: US ORGANIC GROUP CORP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated March 29, 2013

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  • ACTIVE INGREDIENT

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

    *=Certified Organic Ingredient


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  • PURPOSE

    Anti-Itch

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  • INDICATIONS & USAGE

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

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  • ASK DOCTOR

    Ask a doctor if condition worsen

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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  • 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

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  • 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

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  • DOSAGE & ADMINISTRATION

    Apply affected area and rub rapidly for 10 seconds.

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  • 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

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  • INGREDIENTS AND APPEARANCE
    ANTI ITCH BALM  
    peppermint oil ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:57285-100
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Peppermint Oil (UNII: AV092KU4JH) (Peppermint - UNII:V95R5KMY2B) Peppermint Oil 0.0952 g  in 28 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57285-100-02 1 in 1 CARTON
    1 NDC:57285-100-01 28 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 03/29/2013
    Labeler - US ORGANIC GROUP CORP (078748578)
    Registrant - LEORARD MOON (078748578)
    Establishment
    Name Address ID/FEI Business Operations
    US ORGANIC GROUP CORP 078748578 manufacture(57285-100)
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