ARNICA PLUS - arnica montana and hypericum perforatum cream
HOMEOLAB USA INC

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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ACTIVE INGREDIENTS

Arnica montana (Leopard`s bane) 1X

Hypericum perforatum (St John`s wort) 1X

PURPOSE

Pain, bruises, sprains.

Bruises, strains.

The letters HPUS indicate that these ingredients are officially included in the Homeopathic Pharmacopoeia of the United States.

USES

This homeopathic medicine helps relieve symptoms associated with:

- minor bruises

- strains

- sprains.

WARNINGS

For external use only.

Do not use if tube seal is broken and on broken skin.

When using this product, avoid contact with eyes.

Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Apply a thin layer to the affected area, rub in gently.

Repeat 3 times a day or as needed.

OTHER INFORMATION

Store at room temperature (68-77F).

INACTIVE INGREDIENTS

Carbomer, ceteareth-12, cetearyl alcohol, cetyl alcohol, cetyl palmitate, DMDM hydantoin, glycerin, glyceryl cocoate, glyceryl stearate, iodopropynyl butylcarbamate, isopropyl myristate, isopropyl palmitate, octyldodecanol, PEG-20 glyceryl stearate, PEG-100 stearate, purified water, sodium hydroxide, sorbitan stearate.

CARTON

image of carton label

ARNICA PLUS
arnica montana, hypericum perforatum cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60512-9082
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (ARNICA MONTANA)	ARNICA MONTANA	1 [hp_X] in 50 g
HYPERICUM PERFORATUM (HYPERICUM PERFORATUM)	HYPERICUM PERFORATUM	1 [hp_X] in 50 g

Inactive Ingredients
Ingredient Name	Strength
WATER
GLYCERYL MONOSTEARATE
OCTYLDODECANOL
ISOPROPYL PALMITATE
ISOPROPYL MYRISTATE
PEG-20 GLYCERYL STEARATE
CETEARETH-12
CETYL PALMITATE
GLYCERYL COCOATE
CETOSTEARYL ALCOHOL
SORBITAN MONOSTEARATE
CETYL ALCOHOL
GLYCERIN
POLYOXYL 100 STEARATE
DMDM HYDANTOIN
IODOPROPYNYL BUTYLCARBAMATE
CARBOMER HOMOPOLYMER TYPE A
SODIUM HYDROXIDE

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:60512-9082-1	1 TUBE ( TUBE) in 1 CARTON	contains a TUBE
1		50 g in 1 TUBE	This package is contained within the CARTON (60512-9082-1)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/01/2011

Labeler - HOMEOLAB USA INC (202032533)

Establishment
Name	Address	ID/FEI	Operations
HOMEOLAB USA INC		202032533	manufacture

Revised: 03/2011 HOMEOLAB USA INC