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Drug Facts
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Ona stick
Magnolia, Tx, 77354
Arnica
FDA Label NDC 82610-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ona Stick Usa Llc for the product Arnica (NDC 82610-003). 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 other, otc - purpose, usesas a homeopathic medicine, these "uses" have not been evaluated by the food & drug administration., warnings, otc - do not use, when using this product, stop use and ask a doctor if, 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
| Active ingredients | Purpose |
|---|---|
| Arnica montana (Arnica), 1X, 2.5% Calendula officinalis (Calendula), 1X, 1.8% Hamamelis virginiana (Witch Hazel), 1X, 2.5% Matricaria chamomilla (Chamomile), 1X, 2.0% | For relief of minor pain, discomfort, bumps & bruises |
Usesas A Homeopathic Medicine, These "Uses" Have Not Been Evaluated By The Food & Drug Administration.
Temporarily relieves minor pain, discomfort, bumps and bruises due to minor injuries, falls, trauma and overexertion.
Warnings
For external use only.
Otc - Do Not Use
Do not use if you are allergic to any of the active ingredients or inactive ingredients in this product.
When Using This Product
- avoid contact with eyes and mouth
- do not use on wounds or irritated or damaged skin
- use only as directed
- do not apply tight wraps or bandages to treated areas
- do not apply heat to treated areas immediately before or after use
Stop Use And Ask A Doctor If
- symptoms persist more than 3 days or worsen
- symptoms clear up and then reoccur 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.
Directions
Apply a thin layer to affected areas, massaging onto skin. Repeat as needed. If heat or ice are applied to skin, wait 10 minutes before applying product.
Other Information
Keep cap firmly in place between uses. Store at room temperature in a dry place. Retain this tip card for full Drug Facts.
Inactive Ingredients
Beeswax, Carnauba Oil, Castor Oil, Cocoa Butter, Coconut Oil, Isopropyl Myristate, Lanolin, Mineral Oil, Oleic Acid, Ozoquerite Wax, Stearyl Alcohol.
Questions
call 210.629.1343
Principal Display Panel - 14 G Tube Blister Pack
CHAMOMILE • CALENDULA • WITCH HAZEL
Natural active
ingredients
arnica
oná stick®
Pain & bruise balm
Homeopathic medicine
| Wellness at hand.
Goodbye bruises!
Pain & bruise balm
Homeopathic medicine
NET WT 0.5 oz (14 g)
Principal Display Panel (14 g Tube Blister Pack)
* Please review the disclaimer below.
