Otc - Active Ingredient
Active ingredient, ...........................Arnica Montana HPUs 7%
Arnica Herbal Care Cream
FDA Label NDC 85284-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bloomwell Gardens Llc for the product Arnica Herbal Care Cream (NDC 85284-007). 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, inactive ingredient, otc - purpose, dosage & administration, warnings, otc - stop use, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Inactive ingredients
Purified Water, Vitamin K, Vitamin C , Vitamin E, Coconut oil, Alcohol
Carbomer, sodium Hydroxide, Vanillyl Butyl Ether
Otc - Purpose
Purpose, .......................... Bruise & Pain Relief
Dosage & Administration
Directions
.Apply a thin layer of cream to the affected area as soon as possible after minor injury.
.Repeat 3 times a day as needed.
.If heat or ice is applied, wait 5 minutes before applying cream.
Warnings
Warnings
For external use only
. Do not use on broken skin
. Avoid contact with eyes
Otc - Stop Use
*Stop use and ask a doctor if condition persists for more than 3 days or worsens, or if symptoms clear up and occur again 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.
Indications & Usage
Uses
Temporarily relieves pain, swelling, and discoloration associated with
bruises, minor injuries, muscle soreness, and bumps.
* Please review the disclaimer below.
