Otc - Active Ingredient
Active ingredient:
- Arnica Montana 1X HPUS (7%)
Tagrid Arnica Bruise Arnica Montana 1x Hpus (7%) Cream
FDA Label NDC 85384-0015
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tagrid Llc for the product Tagrid Arnica Bruise Arnica Montana 1x Hpus (7%) (NDC 85384-0015). 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 - 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
Otc - Purpose
Purpuse:Bruise Relief.
"HPUS" indicates that this ingredient is officially monographed in the Homeopathic Pharmacopoeia of the United States.
Indications & Usage
Uses: Temporarily relieves pain, swelling, and discoloration associated with:
- Bruises
- Minor falls
- Sports injuries
- Muscle soreness
Warnings
For external use only
Otc - Do Not Use
Do not apply to broken skin or open wounds. Avoid contact with eyes.
Otc - When Using
When using this product
Avoid contact with eyes.
Otc - Stop Use
Stop use and ask a doctor if
- Condition worsens
- Symptoms persist for more than 7 days or clear up and occur again within a few days.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding
Ask 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:
- Apply a thin layer to the affected area 2 to 3 times daily.
- Gently massage until absorbed.
- Use as soon as possible after minor injury.
Inactive Ingredient
Inactive ingredients:
- Purified Water
- Butyrospermum Parkii (Shea Butter)
- Tocopherol (Vitamin E)
- Tetrahexyldecyl Ascorbate (Vitamin C)
- Allantoin
- Aloe Barbadensis Leaf Juice
- Calendula Officinalis Flower Extract
- Centella Asiatica Extract
- Portulaca Oleracea Extract
- Cocos Nucifera (Coconut) Oil
- Phytonadione (Vitamin K)
- Escin
Otc - Questions
Questions or comments?
Contact us at [email protected]
Package Label.Principal Display Panel
Arnica.jpg (Arnica)
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