Otc - Active Ingredient
Arnica montana 1X HPUS 7% **
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Arnicare Bruise Cream
FDA Label NDC 0220-9085
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 Bruise (NDC 0220-9085). 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 - ask doctor, 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
Reduces pain, swelling, and discoloration from bruises*
Indications & Usage
Uses*
reduces symptoms of bruising such as:
- pain
- swelling
- discoloration
Warnings
For external use only.
Otc - Do Not Use
Do not use if you are allergic to Arnica montana or to any of this product's inactive ingredients.
Otc - When Using
When using this product
- avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin
- use only as directed
- 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 - Ask Doctor
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. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
Apply a thin layer of Arnicare Bruise to affected area and massage gently as soon as possible after minor bruise. Repeat 3 times a day or as needed. If heat or ice is applied, wait 5 minutes before applying Arnicare Bruise.
Other
Other information
- do not use if glued carton end flaps are open or if the tube seal is broken
- store at 68-77° F (20-25° C)
Net Wt. 1.4 oz (40g)
Bruise Relief*
Pain Swelling Discoloration*
Moisturizing Formula
Fade Bruises
Fragrance-Free
ɨ 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.
Inactive Ingredient
alcohol, caprylyl glycol, carbomer, cetyl palmitate, glycerin, lauroyl macrogoglycerides, pegoxol-7 stearate, purified water, sodium hydroxide, sorbic acid, 1,2-hexanediol
Otc - Questions
Package Label.Principal Display Panel
* Please review the disclaimer below.
