FDA.reportPublic FDA data

ARNICA HERBAL CARE cream

Manufacturer
BLOOMWELL GARDENS LLC | Jiangxi Hemei Pharmaceutical Co., Ltd.
Effective date
2025-08-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:09:10

Label at a glance#

ProductARNICA HERBAL CARE cream
Active ingredientARNICA MONTANA
Label structure9 sections

Label contents#

Full prescribing information#

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.

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.

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves pain, swelling, and discoloration associated with

bruises, minor injuries, muscle soreness, and bumps.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display Panel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85284-007-01ARNICA HERBAL CARE cream120 g in 1 BOTTLE, PLASTICCREAM1201

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85284-00785284-007-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
VITAMIN E POLYETHYLENE GLYCOL SUCCINATEO03S90U1F2IACT
VITAMIN K-DEPENDENT PROTEIN CY2RU654EXBIACT
ALCOHOL3K9958V90MIACT
ARNICA MONTANAO80TY208ZWACTIB
SODIUM HYDROXIDE55X04QC32IIACT
VANILLYL BUTYL ETHERS2ULN37C9RIACT
WATER059QF0KO0RIACT
CARBOMER0A5MM307FCIACT
COCONUT OILQ9L0O73W7LIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3b498dd3-1ae3-193d-e063-6294a90a77e43b4993d4-1a42-067e-e063-6394a90a4a392025-08-01WarningsExact identifier
spl id: 3b498dd3-1ae3-193d-e063-6294a90a77e4
spl set id: 3b4993d4-1a42-067e-e063-6394a90a4a39

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.