ARNICA HERBAL CARE cream
3b4993d4-1a42-067e-e063-6394a90a4a39
HUMAN OTC DRUG LABEL
Aug 1, 2025
BLOOMWELL GARDENS LLC
DUNS: 124839891
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Amica Montana HPUS
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (9)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
Uses
Temporarily relieves pain, swelling, and discoloration associated with
bruises, minor injuries, muscle soreness, and bumps.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
*Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
OTC - ACTIVE INGREDIENT SECTION
Active ingredient, ...........................Arnica Montana HPUs 7%
INACTIVE INGREDIENT SECTION
Inactive ingredients
Purified Water, Vitamin K, Vitamin C , Vitamin E, Coconut oil, Alcohol
Carbomer, sodium Hydroxide, Vanillyl Butyl Ether
OTC - PURPOSE SECTION
Purpose, .......................... Bruise & Pain Relief
DOSAGE & ADMINISTRATION SECTION
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 SECTION
Warnings
For external use only
. Do not use on broken skin
. Avoid contact with eyes
OTC - STOP USE SECTION
*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.