Label: ANTI ITCH BALM- peppermint oil ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 57285-100-01, 57285-100-02 - Packager: US ORGANIC GROUP CORP
- Category: HUMAN OTC DRUG LABEL
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
- PURPOSE
- INDICATIONS & USAGE
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS
- INSTRUCTIONS FOR USE
- PRINCIPAL DISPLAY PANEL
- DOSAGE & ADMINISTRATION
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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 -
INGREDIENTS AND APPEARANCE
ANTI ITCH BALM
peppermint oil ointmentProduct 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)