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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:57285-100
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Peppermint Oil (Peppermint) Peppermint Oil0.0952 g  in 28 g
Inactive Ingredients
Ingredient NameStrength
JOJOBA OIL 
SUNFLOWER OIL 
SHEA BUTTER 
YELLOW WAX 
TAMANU OIL 
EVENING PRIMROSE OIL 
ROSEMARY OIL 
.ALPHA.-TOCOPHEROL 
LAVENDER OIL 
TEA TREE OIL 
CHAMOMILE FLOWER OIL 
CHAMAEMELUM NOBILE FLOWER OIL 
FRANKINCENSE OIL 
ACHILLEA MILLEFOLIUM 
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)

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