FDA Label for Arnica Recovery
View Indications, Usage & Precautions
Arnica Recovery Product Label
The following document was submitted to the FDA by the labeler of this product Nartex Laboratorios Homeopaticos Sa De Cv. 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
Arnica montana 6C HPUS
Otc - Purpose
Arnica montana.......6C HPUS*..........Anti-inflammatory
*The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. C is a homeopathic dilution. See www.nartexlabsusa.com for more information. Active ingredients are preparaed in accordance with the Homeopathic Pharmacopoeia of the United States, and are therefore non-toxic and have no known side effects.
Indications & Usage
For the temporary relief of
- sore muscles
- bruises
- sprains
as per homeopathic materia medica
Product uses are based on Homeopathic Materia Medica. These "Uses" have not been evaluated by teh Food and Drug Administration. This product has not been clinically tested by Nartex Labs USA, Inc.
Warnings
Do not use if you have an allergy or hypersensitivity to the components of the formula.
Otc - Stop Use
Stop and ask a physician if:
- condition worsens
- if symptoms persist for more than 7 days or clear up and occur again within a few days
- rash develops
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, consult a health professional before use.
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 4 years of age and older: take 2 tablets every 6 hours, slowly dissolving in mouth
- children under 4 years of age: consult a physician
Storage And Handling
store in a cool and dry place
Inactive Ingredient
Gelatin, lactose, magnesium stearate, potato starch, talc
Otc - Questions
Questions or comments? [email protected] or call 1-877-248-1970 between 9am and 5pm CST
Description
Distributed by:
Nartex Labs USA, Inc.
11711 Memorial Dr. #685
Houston TX 77024
Product claims are based on Homeopathic Materia Medica. This product has not been clinically tested by Nartex.
Keep carton. It contains important information.
For you protection, this bottle has a seal around the neck. Attention: do not use if hte neck seal is broken.
This product is HOMEOPATHIC. Its claim and efficacy are based on homeopathic research and clinical experience. This product has not been evaluated for efficacy by FDA with the same rules and procedures as those for other non-homeopathic drugs. For more information on homeopathy visit www.nartexlabsusa.com before using this product.
Package Label.Principal Display Panel
NDC 34666-010-60
Arnica
Recovery Nartex
For Sore Muscles and Bruises*
Directions
2 tablets every 6 hours**
Homeopathic
60 Tablets
*Based on Homeopathic Materia Medica
**See directions at the Back.
* Please review the disclaimer below.