FDA Label for Arnicare
View Indications, Usage & Precautions
Arnicare Product Label
The following document was submitted to the FDA by the labeler of this product Laboratoires Boiron. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredient**
Arnica montana 1X HPUS 7%
The letters HPUS indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States.
Otc - Purpose
Purpose*
Arnica montana 1X HPUS Relieves muscle pain & stiffness, swelling from injuries, discoloration from bruises
Indications & Usage
Uses*
temporarily relieves muscle pain and stiffness due to:
- minor injuries
- overexertion
- falls
- reduces symptoms of bruising such as:
- pain
- swelling
- discoloration
Warnings
Warnings
For external use only.
Do not use if you are allergic to Arnica montana or to any of this product's inactive ingredients.
When using this product
avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin.
use only as directed
dryness or irritation may occur
do not tightly wrap or bandage the treated area
do not apply heat or ice to treated area immediately before or after use.
Otc - Stop Use
Stop use and ask a doctor if
- condition persists for more than 3 days or worsens
- symptoms clear up and occur again within a few days.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
Apply a thin layer of Arnicare Gel to the affected area as soon as possible after minor injury. Repeat 3 times a day or as needed. If heat or ice is applied, wait 5 minutes before applying Arnicare
Arnicare Gel Roll-On - Shake well before each use. With the applicator facing down, lightly squeeze the tube then roll ball against skin to apply a thin layer of the product to affected area. Massage gently into skin 3 times a day or as needed. If heat or ice is applied, wait 5 minutes before applying Arnicare Roll-on.
Inactive Ingredient
Alcohol, carbomer, sodium hydroxide. purified water
Other
Other information
do not use if glued carton end flaps are open or if the tube seal is broken
0.5 oz (14g)
1.5 oz (45g)
2.6 oz (75g)
4.2 oz (120g)
Pain Relief*
Muscle Pain & Stiffness Swelling from Injuries Bruises*
Homeopathic mother tincture made from Arnica montana fresh whole plant.
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
*C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.
Otc - Questions
Questions, Comments?
www.boironusa.com
1-800-BOIRON-1 (1-800-264-7661)
Boiron Information Center
Newtown Square, PA 19073
* Please review the disclaimer below.