Otc - Active Ingredient
Active ingredients**
Arnica montana 1X HPUS 7%
Harpagophytum 1X HPUS 3%
The letter "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Arnicare Arthritis Cream
FDA Label NDC 0220-9077
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Boiron for the product Arnicare Arthritis (NDC 0220-9077). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose*
Arnica montana 1X HPUS 7% ... Relieves muscle pain and stiffness, discoloration from bruises
Harpagophytum 1X HPUS 3% ... Relieves joint discomfort and stiffness associated with arthritis pain
Indications & Usage
Uses*
temporarily relieves minor joint and muscle paid and stiffness due to:
arthritis
minor injuries
overexertion
falls
repetitive motions
Warnings
For external use only.
Otc - Do Not Use
- if you are allergic to Arnica montana, Harpagophytum, or to any of this products inactive ingredients
- with other topical products for pain.
Otc - When Using
- 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 the treated area immediately before or after use.
Otc - Stop Use
Stop use and ask a doctor if
- conditions persists for more than 7 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. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- Adults and children 12 years of age and older: Apply a thin layer of Arnicare Arthritis to affected area as soon as possible at the onset of symptoms up to 4 times a day. If heat or ice is applied, wait 5 minutes before applying Arnicare Arthritis.
- Children under 12 years of age: Ask a doctor.
Other
- do not use if glued carton end flaps are open or if the tube seal is broken
- store below 77° F (25° C)
2.5 oz (70 g)
0.5 oz (14 g)
Arthritis Pain Relief*
Quickly Absorbed
Fragrance-Free
Powered by Plants
Takes pain away
Suitable for Use on All Joints
No Known Drug Interactions
No Harsh Ingredients
No Burning or Stinging
*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.
Inactive Ingredient
acrylamide, alcohol, chlorhexidine digluconate, glycerin, isohexadecane, polysorbate 80, purified water, sodium acryloyldimethyltaurate copolymer, sweet almond oil
Otc - Questions
Questions or comments?
Arnicare.com
BoironUSA.com
1-800-BOIRON-1 (1-800-264-7661)
Made in France
Distributed by Boiron, Inc.
Newtown Square, PA 19073
* Please review the disclaimer below.
