Otc - Active Ingredient
Arnica Montana 1X HPUS
The letters “HPUS” indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Arnica Bruise Cream
FDA Label NDC 85398-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Beautivity Llc for the product Arnica Bruise Cream (NDC 85398-005). 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 - 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
Reduces pain, swelling, and discoloration from bruises
Indications & Usage
- Helps reduce the appearance of bruises, swelling, and skin discoloration.
- Soothes discomfort caused by minor injuries
Warnings
For external use only.
Otc - Do Not Use
if you are allergic to Arnica Montana or any inactive ingredients in this product.
Otc - When Using
- Avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin.
- Use only as directed.
- Do not tightly wrap or bandage the treated area.
- Do not apply heat or ice to the treated area immediately before or after use.
Otc - Stop Use
Stop use and ask a doctor if:
- Condition persists for more than 3 days or worsens.
- Symptoms clear up and occur again within a few days
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
- Apply a thin layer of Arnica Bruise Cream to 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 Arnica Bruise Cream
Other Safety Information
- Do not use if glued carton end flaps are open or if the tube seal is broken
- Store at 68-77°F (20-25°C)
- Keep the cap tightly closed after use
Inactive Ingredient
Water, Glycerin, Caprylic/capric Triglyceride, Butyrospermum Parkii (Shea) Butter, Petrolatum, Methylpropanediol, Cetearyl Alcohol, Cetearyl Glucoside, Glucose, Dimethicone, Butylene Glycol, Chrysanthellum Indicum Extract, Citrus Aurantium Dulcis (Orange) Seed Oil Unsaponifiables, Portulaca Oleracea Extract, Pelargonium Graveolens Extract, Aloe Barbadensis Extract, Sodium Benzoate, Potassium Sorbate.
Otc - Questions
* Please review the disclaimer below.
