Otc - Active Ingredient
Arnicare Cream:
Arnica Montana 1X HPUS 7%*
Arnica 30 C pellets:
Arnica Montana 30C HPUS (0.443 mg)*
Arnica Value Pack Kit
FDA Label NDC 0220-9047
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 Arnica Value Pack (NDC 0220-9047). 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, inactive ingredient, how supplied, otc - purpose, storage and handling, otc - questions, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Arnicare cream and Arnica 30 C pellets
Temporary relieves muscle pain and stiffness due to minor injuries, overexertion and falls.
Reduces pain, swelling and discoloration from bruises.
Inactive Ingredient
Arnicare Cream Value Pack:
Cream: alcohol, caprylyl, glycol, carbomer, cetyl palmitate, EDTA disodium, glycerin, lauroyl macrogolglycerides, pegoxol-7 stearate, purified water, sodium hydroxide, sorbic acid, 1,2-hexanediol.
Pellets: Lactose, Sucrose.
Arnicare Cream Value Pack (without disodium EDTA):
Cream: alcohol, caprylyl, glycol, carbomer, cetyl palmitate, glycerin, lauroyl macrogolglycerides, pegoxol-7 stearate, purified water, sodium hydroxide, sorbic acid, 1,2-hexanediol.
Pellets: Lactose, Sucrose.
How Supplied
Cream:
1 tube 2.5 OZ (70g)
Pellets:
1 tube approx. 80 pellets each, 3.8g (0.133 oz.)
Otc - Purpose
Cream:
Arnica Montana 1X HPUS-7% ..... Trauma, muscle, pain and stiffness, swelling from injuries, discoloration from bruising.
Pellets:
Arnica montana 30C HPUS .......... Trauma, bruises and muscle soreness.
Storage And Handling
Store at 68-77 o F (20-25 o C)
Otc - Questions
Questions, Comments
www.arnicare.com
[email protected]
1-800-BOIRON-1
(1-800-264-7661)
Otc - Ask Doctor
Otc - Stop Use
Cream:
Stop use and ask a doctor if condition persists for more than 3 days or worsens.
Pellets:
Stop use and ask a doctor if condition persists for more than 3 days or worsens.
Otc - Keep Out Of Reach Of Children
Cream:
Keep out of reach of children
If swallowed get medical help or contact a Poison Control Center right away.
Pellets:
Keep out of reach of children
Otc - When Using
avoid contact with eyes, mucus membranes, wounds, damaged or irrated skin
use only as directed
do not tightly wrap or bandage the treated area
do not apply heat or ice to the trated area immediately before or after use
Drug Interactions
Unscented -Paraben free -Great for massage - Works naturally with your body.
Warnings
Arnicare Cream:
For external use only.
Avoid contact with eyes and with open wounds.
Dosage & Administration
Cream:
Apply a thin layer of Arnicare Cream of affected area and massage gently 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 Cream.
Pellets:
Adults and children 2 years of age and older: Dissolve 5 pellets in the mouth 3 times a day until relieved or as directed by a doctor.
How to use Arnica 30C Pellets: Turn tube upside down. Twist until 5 pellets are dispensed
Recent Major Changes
How to use Arnica 30C pellets tube instructions added
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Other
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.
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
For general pain relief, Arnica 30C pellets can be take alone or as a complement to Arnicare Cream.
Non-drowsy
No known drug interactions
Local & General Pain
Combine for total relief
* Please review the disclaimer below.
