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Name:Arnica Plus
Manufacturer:Homeolab Usa Inc
Category:Homeopathic Marketed Drugs


DRUG FACTS

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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DRUG FACTS

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



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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