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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:53499-5090
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA1 [hp_X]  in 28 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
CARBOMER HOMOPOLYMER TYPE C 
WATER 
WITCH HAZEL 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53499-5090-41 in 1 CARTON
128 g in 1 TUBE
2NDC:53499-5090-81 in 1 CARTON
278 g in 1 TUBE
3NDC:53499-5090-11 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/01/2011
Labeler - Nature's Way Products, Inc. (153970520)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe Mexico SA DE CV824412357manufacture

Revised: 4/2011
Document Id: ad4c9b93-91cd-4598-bb22-5a5f5b79e760
Set id: 935bf19d-a32c-49b8-a5cc-13e7ddfb23fe
Version: 3
Effective Time: 20110416
 
Nature's Way Products, Inc.