Update-85398-005-01

Update-85398-005-01
SPL v2
SPL
SPL Set ID 348f3161-8abf-26d7-e063-6294a90a41dc
Route
TOPICAL
Published
Effective Date 2025-05-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (1 [hp_X])
Inactive Ingredients
Glucose Potassium Sorbate Portulaca Oleracea Whole Butyrospermum Parkii (shea) Butter Cetearyl Alcohol Butylene Glycol Pelargonium Graveolens Whole Sodium Benzoate Cetearyl Glucoside Chrysanthemum Indicum Whole Dimethicone Citrus Aurantium Dulcis (orange) Seed Oil Methylpropanediol Caprylic/capric Triglyceride Aloe Barbadensis Leaf Petrolatum Water Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2025-05-30
Description

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.

Medication Information

Warnings and Precautions

For external use only.

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

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.

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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
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 50570-1

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

Section 51727-6

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.

Section 51945-4

Section 53413-1

[email protected]

Section 55105-1

Reduces pain, swelling, and discoloration from bruises

Section 55106-9

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.

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

For external use only.

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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
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 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

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.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

[email protected]

Section 55105-1 (55105-1)

Reduces pain, swelling, and discoloration from bruises

Section 55106-9 (55106-9)

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.

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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:12:03.803589 · Updated: 2026-03-14T23:17:43.376799