Otc - Active Ingredient
Arnica Montana 1X HPUS 7%*
Arnicare Cream
FDA Label NDC 0220-9021
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Laboratoires Boiron for the product Arnicare (NDC 0220-9021). 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, indications & usage, otc - do not use, dosage & administration, inactive ingredient, how supplied, otc - purpose, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Temporarily relieves muscle pain and stiffness due to minor injuries, overexertion and falls. Reduces pain, swelling and discoloration from bruises.
Otc - Do Not Use
Do not use if glued carton en flaps are open or if the tube seal is broken.
Dosage & Administration
Apply a thin layer of Arnicare Cream to affected area and massage after minor injury. Repeat 3 times a day or as needed.
Inactive Ingredient
Arnicare Cream
Alcohol, Caprylyl glycol, carbomer, cetyl palmitate, EDTA disodium, glycerin, lauroyl macrogolglycerides, pegoxol-7 stearate, purified water, sodium hydroxide, sorbic acid, 1,2-hexanediol
Arnicare Cream (without disodium EDTA)
Alcohol, Caprylyl glycol, carbomer, cetyl palmitate, EDTA disodium, glycerin, lauroyl macrogolglycerides, pegoxol-7 stearate, purified water, sodium hydroxide, sorbic acid, 1,2-hexanediol
How Supplied
Tube 2.5 OZ (70 G)
or
Tube 1.33 OZ (40G)
or
Tube 4.2 OZ (120G)
or
Tube 0.5 OZ (14G)
Otc - Purpose
Arnica Montana 1X ... Trauma, muscle pain and stiffness, swelling from injuries, discoloration from bruising.
Storage And Handling
Store at 68-77
O F (20-25
O C)
Otc - Questions
Questions, Comments?
www.arnicare.com
www.boironusa.com
1-800-BOIRON-1 (1-800-264-7661)
Distributed by Boiron Inc.
Newtown Square, PA 19073-3267
Otc - Ask Doctor
Otc - Stop Use
Stop use and ask doctor if condition persists for more than 3 days or worsens.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Otc - Pregnancy Or Breast Feeding
Otc - When Using
Drug Interactions
Unscented - Paraben-Free - Great for massage - Works naturally with your body
Warnings
For external use only
Avoid contact with eyes, mucous membranes, damaged skin or wounds.
Do not use if you are allergic to Arnica montana or any of the this product's inactive ingredients.
When using this product, use only as directed: do not tightly wrap or bandage, do not apply heat or ice to the treated area immediately before or after use.
If swallowed, get medical help or contact a Poison Control Center right away.
Other
*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.
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
ɨ Homeopathic mother tincture made from Arnica montana fresh whole plant.
* Please review the disclaimer below.
