FDA.reportPublic FDA data

Update-85398-015-01

Manufacturer
Beautivity LLC
Effective date
2026-06-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
monthly-update
Hydrated at
2026-07-17 21:34:17

Label at a glance#

ProductHermon Arnica Cream sensitive skin formula 2 oz
Active ingredientARNICA MONTANA
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Arnica Montana 1X HPUS

The letters "HPUS" indicate that the components in this productare officially monographed in the Homeopathic Pharmacopoeia of the United States.

OTC - PURPOSE SECTION

Reduces pain, swelling, anddiscolorationfrom bruises

DOSAGE & ADMINISTRATION SECTION

  • Helps reduce the appearance of bruises, swelling,and skin discoloration
  • Soothes discomfort caused by minor injuries

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

OTC - DO NOT USE SECTION

if you are allergic to Arnica Montana or any inactive ingredients in this product.

OTC - WHEN USING SECTION

  • 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 - ASK DOCTOR SECTION

  • 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 SECTION

If swallowed, get medical help orcontact a Poison Control Center right away

INDICATIONS & USAGE SECTION

  • 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
  • lf 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 SECTION

Aqua, Glycerin, Propylene Glycol, Alcohol, Carbomer, Vitamin K2, Triethanolamine, Sodium Hydroxide, Phenoxyethanol

OTC - QUESTIONS SECTION

service@hermonhealth.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagePackage

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130199284535022GTIN-13: 0199284535022
EAN-13: 0199284535022
GTIN-12: 199284535022
UPC-A: 199284535022
GTIN storage (14 digits): 00199284535022		arnica cream.jpg

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85398-01585398-015-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
AQUA059QF0KO0RIACT
TRIETHANOLAMINE9O3K93S3TKIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER0A5MM307FCIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM HYDROXIDE55X04QC32IIACT
ARNICA MONTANAO80TY208ZWACTIB
MENAQUINONE 671ANL51TLAIACT
PHENOXYETHANOLHIE492ZZ3TIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-03-02full-release2026-06-01 02:37:48
12025-09-25monthly-update2026-06-03 17:37:49

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
Hermon Arnica Cream sensitive skin formula 2 ozARNICA MONTANA 1X HPUSBeautivity LLC3f9d4d78-81fc-717f-e063-6394a90a5b8a2026-06-29WarningsExact identifier
ndc (package): 85398-015-01
ndc (product): 85398-015
ndc11 (package): 85398001501
spl id: 55675bd7-5ec9-3162-e063-6294a90afebf
spl set id: 3f9d4d78-81fc-717f-e063-6394a90a5b8a

Reported adverse events (FAERS/openFDA)#

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