ANTI ITCH BALM  - peppermint oil ointment 
US ORGANIC GROUP CORP

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.

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Drug Facts

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

*=Certified Organic Ingredient


Anti-Itch

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

Ask a doctor if condition worsen

Keep out of reach of children.

- For external use only

- Do not use in or near the eyes

- Keep out of reach of children

- Ask a doctor if condition worsen

- 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

image of anti itch

Apply affected area and rub rapidly for 10 seconds.

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

ANTI ITCH BALM  
peppermint oil ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57285-100
Route of Administration TOPICAL DEA Schedule     
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)

Revised: 3/2013
Document Id: 7aff6e22-67f3-408c-adcc-e2978f1c1508
Set id: c0cb1412-8a46-4f41-9162-10e6f7237ef9
Version: 3
Effective Time: 20130329
 
US ORGANIC GROUP CORP