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Name:Arniflora
Manufacturer:Nature's Way Products, Inc.
Category:Homeopathic Marketed Drugs


Arniflora

ARNIFLORA   - arnica montana gel 
Nature's Way Products, 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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Arniflora

Active Ingredient:

ARNICA MONTANA  1 X HPUS 8%

Inactive Ingredients:

ALCOHOL

CARBOMER HOMOPOLYMER TYPE C

NaOH 32% (AQUEOUS)

WITCH HAZEL (ALCOHOLIC)

WATER




Dosage and Administration:

Boericke and Tafel Brand:

Directions:

Adults and Children 2 years of age and older: Apply to affected area not more than 4 times daily.  Massage gently or use compress.
Children under 2: Consult a doctor.


Indications and Usage:

For the temporary relief of bruises and minor muscle and joint pain, swelling and stiffness from over-exercising, sprains, falls, blows, and sports injuries.


Purpose:

For the temporary relief of bruises and minor muscle and joint pain,
swelling and stiffness from over-exercising, sprains, falls, blows, and sports
injuries.


Warnings

Do not use on broken skin.  For external use only.  Avoid contact with eyes. Discontinue use of this product and consult a doctor if redness occurs or condition worsens or symptoms persist for more than 7 days or clear up and recur again within a few days. Keep out of reach of children.  In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.


Keep out of Reach of Children:

Keep out of reach of children.

Ask the Doctor:

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.


Package Label.Principal Display Panel:


ARNIFLORA Arnica Gel 1 OZ 21825090 10R0


ARNIFLORA Arnica Gel 1 OZ 21825090 10R0





















ARNIFLORA  
arnica montana gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-5090
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 28 g
Inactive Ingredients
Ingredient Name Strength
ALCOHOL  
CARBOMER HOMOPOLYMER TYPE C  
WATER  
WITCH HAZEL  
SODIUM HYDROXIDE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53499-5090-4 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 28 g in 1 TUBE This package is contained within the CARTON (53499-5090-4)
2 NDC:53499-5090-8 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
2 78 g in 1 TUBE This package is contained within the CARTON (53499-5090-8)
3 NDC:53499-5090-1 1 g in 1 PACKET None

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

Labeler - Nature's Way Products, Inc. (153970520)
Establishment
Name Address ID/FEI Operations
Schwabe Mexico SA DE CV 824412357 manufacture

Revised: 04/2011 Nature's Way Products, Inc.



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


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