update - 87212-001

update - 87212-001
SPL v2
SPL
SPL Set ID 4340b0d2-e350-59bf-e063-6394a90aaccb
Route
topical
Published
Effective Date 2025-11-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
arnica montana (1.695 g)
Inactive Ingredients
aloe barbadensis leaf juice phytonadione epoxide sodium ascorbyl phosphate pelargonium graveolens whole water sodium benzoate caprylic/capric triglyceride potassium sorbate levoglucose butylene glycol glycerin petrolatum portulaca oleracea whole cetearyl alcohol cetearyl glucoside citrus aurantium dulcis (orange) seed oil butyrospermum parkii (shea) butter sophora flavescens root methylpropanediol dimethicone chrysanthellum indicum whole

Identifiers & Packaging

Marketing Status
unapproved homeopathic active Since 2025-11-24
Description

Arnica Montana 1X HPUS 1.5%

Medication Information

Warnings and Precautions

For external use only

Active Ingredient

Arnica Montana

1X HPUS 1.5%

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 1.5%

Section 50565-1

lf swallowed, seek medical advice immediately or contact a Poison Control Center right away.(1-800-222-1222)

Section 50567-7

avoid contact with eyes, mucous membraneswounds, 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

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,

Sophora Angustifolia Root Extract, Phytonadione Epoxide (Vitamin Kl), Sodium Ascorbyl Phosphate(Vitamin C), Sodium Benzoate, Potassium Sorbate

Section 51945-4

Section 53413-1

Email: [email protected]

Section 55105-1

Reduces pain,swelling.and discoloration from bruises

*HPUS indicates that this ingredient is officially included in the Homeopathic Pharmacopeia of the United States.

Section 60561-8

Store at 68-77°F(20-25°C). Keep the cap tightly closed after use. Do not use if glued carton end flaps are open or if the tube seal is broken.

Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Active Ingredient (55106-9)

Arnica Montana

1X HPUS 1.5%

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
Section 50565-1 (50565-1)

lf swallowed, seek medical advice immediately or contact a Poison Control Center right away.(1-800-222-1222)

Section 50567-7 (50567-7)

avoid contact with eyes, mucous membraneswounds, 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)

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,

Sophora Angustifolia Root Extract, Phytonadione Epoxide (Vitamin Kl), Sodium Ascorbyl Phosphate(Vitamin C), Sodium Benzoate, Potassium Sorbate

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Email: [email protected]

Section 55105-1 (55105-1)

Reduces pain,swelling.and discoloration from bruises

*HPUS indicates that this ingredient is officially included in the Homeopathic Pharmacopeia of the United States.

Section 60561-8 (60561-8)

Store at 68-77°F(20-25°C). Keep the cap tightly closed after use. Do not use if glued carton end flaps are open or if the tube seal is broken.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:12:07.683207 · Updated: 2026-03-14T23:17:42.550366