Update-85398-015-01

Update-85398-015-01
SPL v2
SPL
SPL Set ID 3f9d4d78-81fc-717f-e063-6394a90a5b8a
Route
TOPICAL
Published
Effective Date 2025-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (1 [hp_X])
Inactive Ingredients
Aqua Triethanolamine Alcohol Glycerin Carbomer Propylene Glycol Sodium Hydroxide Menaquinone 6 Phenoxyethanol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2025-10-25
Description

Arnica Montana 1X HPUS The letters "HPUS" indicate that the components in this productare officially monographed in the Homeopathic Pharmacopoeia of the United States.

Medication Information

Warnings and Precautions

FOR EXTERNAL USE ONLY.

Indications and Usage
  • 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
Dosage and Administration
  • Helps reduce the appearance of bruises, swelling,and skin discoloration
  • Soothes discomfort caused by minor injuries
Description

Arnica Montana 1X HPUS The letters "HPUS" indicate that the components in this productare officially monographed in the Homeopathic Pharmacopoeia of the United States.

Section 50565-1

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

Section 50567-7
  • 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
Section 50569-3
  • condition persists for more than 3 days or worsens
  • Symptoms clear up and occur again within a few days
Section 50570-1

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

Section 51727-6

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

Section 51945-4

Section 53413-1

[email protected]

Section 55105-1

Reduces pain, swelling, anddiscolorationfrom bruises

Section 55106-9

Arnica Montana 1X HPUS

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

Section 60561-8
  • 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

Structured Label Content

Indications and Usage (34067-9)
  • 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
Dosage and Administration (34068-7)
  • Helps reduce the appearance of bruises, swelling,and skin discoloration
  • Soothes discomfort caused by minor injuries
Warnings and Precautions (34071-1)

FOR EXTERNAL USE ONLY.

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)
  • 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
Section 50569-3 (50569-3)
  • condition persists for more than 3 days or worsens
  • Symptoms clear up and occur again within a few days
Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

[email protected]

Section 55105-1 (55105-1)

Reduces pain, swelling, anddiscolorationfrom bruises

Section 55106-9 (55106-9)

Arnica Montana 1X HPUS

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

Section 60561-8 (60561-8)
  • 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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:12:13.918559 · Updated: 2026-03-14T23:17:43.376799