FDA.reportPublic FDA data

Update-85398-005-01

Manufacturer
Beautivity LLC
Effective date
2026-06-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
monthly-update
Hydrated at
2026-07-17 21:34:18

Label at a glance#

ProductArnica Bruise Cream
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 product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

OTC - PURPOSE SECTION

Reduces pain, swelling, and discoloration from bruises

INDICATIONS & USAGE 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 - STOP USE SECTION

Stop use and ask a doctor if:

  • 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 or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION 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.
  • If 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

Water, Glycerin, Caprylic/capric Triglyceride, Butyrospermum Parkii (Shea) Butter, Petrolatum, Methylpropanediol, Cetearyl Alcohol, Cetearyl Glucoside, Glucose, Dimethicone, Butylene Glycol, Chrysanthellum Indicum Extract, Citrus Aurantium Dulcis (Orange) Seed Oil Unsaponifiables, Portulaca Oleracea Extract, Pelargonium Graveolens Extract, Aloe Barbadensis Extract, Sodium Benzoate, Potassium Sorbate.

OTC - QUESTIONS SECTION

service@hermonhealth.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

arnicabruisearnicabruise

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130199284613942GTIN-13: 0199284613942
EAN-13: 0199284613942
GTIN-12: 199284613942
UPC-A: 199284613942
GTIN storage (14 digits): 00199284613942		Hermon ArnicaBruiseCream.jpg
QR code linkQR Codeq-r.to/BRUISEHermon ArnicaBruiseCream.jpg

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85398-00585398-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLUCOSE5SL0G7R0OKIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PORTULACA OLERACEA WHOLED5J3623SV2IACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
CETEARYL ALCOHOL2DMT128M1SIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PELARGONIUM GRAVEOLENS WHOLE0E553RP62FIACT
SODIUM BENZOATEOJ245FE5EUIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
CHRYSANTHEMUM INDICUM WHOLEO9ECF2PL1FIACT
DIMETHICONE92RU3N3Y1OIACT
CITRUS AURANTIUM DULCIS (ORANGE) SEED OIL9WMM6OQ58AIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
ARNICA MONTANAO80TY208ZWACTIB
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
ALOE BARBADENSIS LEAFZY81Z83H0XIACT
PETROLATUM4T6H12BN9UIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-03-02full-release2026-06-01 02:37:47

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
Arnica Bruise CreamARNICA MONTANABeautivity LLC348f3161-8abf-26d7-e063-6294a90a41dc2026-06-29WarningsExact identifier
ndc (package): 85398-005-01
ndc (product): 85398-005
ndc11 (package): 85398000501
spl id: 5566eb74-e126-fe91-e063-6294a90a47e6
spl set id: 348f3161-8abf-26d7-e063-6294a90a41dc

Reported adverse events (FAERS/openFDA)#

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