ANTI ITCH BALM- peppermint oil ointment

Anti Itch Balm by

Drug Labeling and Warnings

Anti Itch Balm by is a Otc medication manufactured, distributed, or labeled by US ORGANIC GROUP CORP, LEORARD MOON. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 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)