ARNICA HERBAL CARE CREAM- amica montana hpus cream

ARNICA HERBAL CARE cream by

Drug Labeling and Warnings

ARNICA HERBAL CARE cream by is a Otc medication manufactured, distributed, or labeled by BLOOMWELL GARDENS LLC, Jiangxi Hemei Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient, ...........................Arnica Montana HPUs 7%

INACTIVE INGREDIENT

Inactive ingredients

Purified Water, Vitamin K, Vitamin C , Vitamin E, Coconut oil, Alcohol

Carbomer, sodium Hydroxide, Vanillyl Butyl Ether

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

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.

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARNICA HERBAL CARE CREAM 
amica montana hpus cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85284-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
VITAMIN E POLYETHYLENE GLYCOL SUCCINATE (UNII: O03S90U1F2)
VITAMIN K-DEPENDENT PROTEIN C (UNII: Y2RU654EXB)
ALCOHOL (UNII: 3K9958V90M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)
WATER (UNII: 059QF0KO0R)
CARBOMER (UNII: 0A5MM307FC)
COCONUT OIL (UNII: Q9L0O73W7L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85284-007-01	120 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	08/01/2025

Labeler - BLOOMWELL GARDENS LLC (124839891)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Hemei Pharmaceutical Co., Ltd.		724892056	manufacture(85284-007)