ARNIFLORA   - arnica montana gel 
Nature's Way Products, Inc.

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Arniflora

Active Ingredient:

ARNICA MONTANA

Inactive Ingredients:

ALCOHOL

CARBOMER HOMOPOLYMER TYPE C

EDETIC ACID

METHYLPARABEN

PROPYLPARABEN

WATER

TROLAMINE

WITCH HAZEL

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. Carton 21825090

ARNIFLORA   arnica montana   gel

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 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   EDETIC ACID   METHYLPARABEN   PROPYLPARABEN   WATER   TROLAMINE   WITCH HAZEL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 53499-5090-4 1 TUBE In 1 CARTON contains a TUBE 1 28 g In 1 TUBE This package is contained within the CARTON (53499-5090-4) 2 53499-5090-8 1 TUBE In 1 CARTON contains a TUBE 2 78 g In 1 TUBE This package is contained within the CARTON (53499-5090-8)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/01/2006

Labeler - Nature's Way Products, Inc. (153970520)

Establishment
Name	Address	ID/FEI	Operations
Schwabe Mexico SA DE CV		824412357	manufacture

Revised: 11/2010Nature's Way Products, Inc.