Active Ingredients
Arnica TINC HPUS*
Bellis 3X HPUS*
Calendula HPUS*
Chamomila 3X HPUS*
Hamamelis 3x HPUS*
Arnica Montana Nartex Gel
FDA Label NDC 34666-281
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nartex Laboratorios Homeopaticos Sa De Cv for the product Arnica Montana Nartex (NDC 34666-281). 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 active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Arnica TINC HPUS*...............Anti-inflammatory/Pain Relief
Bellis 3X HPUS*.....................Sprains and Bruises
Calendula HPUS*..................Pain Relief
Chamomila 3X HPUS*..........Anti-inflammatory
Hamamelis 3x HPUS*............Anti-inflammatory/Pain Relief
*The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. TINC and X are homeopathic dilutions. See www.nartexlabsusa.com for more information.
Uses
For the temporary relief of:
- sore muscles
- bruises
- sprains
- minor burns
- insect bites
Indications are based on homeopathic materia medica, not clnical tests.
Warnings
For External Use only
Otc - Do Not Use
Do not:
- apply to open wounds
- apply over large areas of the body
Otc - When Using
When using this product
- avoid contact with eyes or mucous membranes
- do not bandage tightly or use with a heating pad
Otc - Stop Use
Stop use and ask doctor if:
- symptoms persis 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 breastfeeding, consult a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.
Directions
Adults and Children over 4 years of age: apply and gently massage the affected area every 4 hours.
Other Information
- Store at room temperature
- Do not use if the safety seal of container is broken or missing.
Inactive Ingredients
Aler Vera (Aloe barbadensis Miller) leaf powder, citric acid, glycerin, menthol, methylparaben sodium, propylene glycol, propylparaben sodium, purified water, xanthan gum
Questions Or Comments?
[email protected] or call 1-877-248-1970 between 9am and 5pm CST.
Other
There is no scientific evidence that the product works.
Product's claims are based only on theories of homepathy from the 1700's that are not accepted by most modern medical experts.
Active ingredients are prepared in accordance with the Homeopathic Pharmacopoeia of the United States, and have no known side effects.
Product of Mexico / Producto de Mexico
Distributed by:
Nartex Labs USA, inc
11711 Memorial Dr. # 685
Houston TX, 77024
www.nartexlabsusa.com
Package Label.Principal Display Panel
HOMEOPATHIC
ARNICA
MONTANA NARTEX
ROLL-ON GEL
For the temporary relief of:
sore muscles, bruises, sprains, minor burns and insect bites.
Net Wt. 2.11 oz (60 g)
* Please review the disclaimer below.
