76986-013

76986-013
SPL v1
SPL
SPL Set ID 425b1b9d-c33a-05e9-e063-6394a90a97a6
Route
TOPICAL
Published
Effective Date 2025-10-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (7 g)
Inactive Ingredients
12-hydroxystearic Acid Water Glyceryl Stearate Se Euphorbia Cerifera (candelilla) Wax Glycerin Fucus Vesiculosus Petrolatum Stearyl Alcohol Ethylene Distearamide 1,2-hexanediol Citrus Reticulata Fruit Oil Vanillyl Butyl Ether Hypericum Perforatum Mineral Oil Ceralifimod Cetyl Alcohol Hydroxyacetophenone Sucrose Acetate Isobutyrate Camphor (synthetic) Butylene Glycol Ceresin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-30

Description

ARNICA MONTANA 7%

Purpose

Promotes local blood circulation, adjunctive therapy for Arthritis、Neuropathy,Tingling, Burning and Numbness. Relieves Muscle Pain, Neuralgia, Stiffness,Swelling,Bruising Symptom.


Medication Information

Purpose

Promotes local blood circulation, adjunctive therapy for Arthritis、Neuropathy,Tingling, Burning and Numbness. Relieves Muscle Pain, Neuralgia, Stiffness,Swelling,Bruising Symptom.

Description

ARNICA MONTANA 7%

Use

Symptomatic treatment of arthritis,neuropathy,tingling, burning and numbness.

Stop Use

Discontinue use if irritation occurs.

Warnings

· For external use only.

· Keep away from fire and flame.

· Ask a doctor before use if pregnant or nursing.

· Prohibited for those who are allergic to this product. Allergic persons should be cautious.

· Prohibit the use of this product when the properties of the product have changed.

Ask Doctor

Discontinue use if irritation occurs.

Directions

Apply to the affected areas 2-3 times daily, massage it till absorbed.

Do Not Use

·by mouth,in nostrils,on wounds or damaged skin.

·if you are under 18 years of age,consult physician.

When Using

Avoid contact with eyes.

Active Ingredient

ARNICA MONTANA 7%

Other Information

·If you are using other drugs, please consult your physician or pharmacist before using this product.

·Shielded from light, sealed, stored at room temperature.

Inactive Ingredients

Petrolatum,Mineral Oil,Ozokerite,Far-Infrared Ceramic Powder,Cera Microcristallina,Stearyl Alcohol,Glyceryl Stearate,Hypericum Perforatum Oil,Camphor,Sucrose Acetate Isobutyrate,Vanillyl Butyl Ether,Cetyl Alcohol,Euphorbia Cerifera (Candelilla) Wax,Hydroxystearic Acid,Water,Butylene Glycol,Citrus Reticulata (Tangerine) Fruit Extract,Glycerin,Fucus Vesiculosus Extract,1,2-Hexanediol,Hydroxyacetophenone

Principal Display Panel

Keep Out of Reach of Children

In case of accidental ingestion, get medical help or contact a poison control center immediately.


Structured Label Content

Use

Symptomatic treatment of arthritis,neuropathy,tingling, burning and numbness.

Purpose

Promotes local blood circulation, adjunctive therapy for Arthritis、Neuropathy,Tingling, Burning and Numbness. Relieves Muscle Pain, Neuralgia, Stiffness,Swelling,Bruising Symptom.

Stop Use

Discontinue use if irritation occurs.

Warnings

· For external use only.

· Keep away from fire and flame.

· Ask a doctor before use if pregnant or nursing.

· Prohibited for those who are allergic to this product. Allergic persons should be cautious.

· Prohibit the use of this product when the properties of the product have changed.

Ask Doctor

Discontinue use if irritation occurs.

Directions

Apply to the affected areas 2-3 times daily, massage it till absorbed.

Do Not Use (Do not use)

·by mouth,in nostrils,on wounds or damaged skin.

·if you are under 18 years of age,consult physician.

When Using

Avoid contact with eyes.

Active Ingredient

ARNICA MONTANA 7%

Other Information (Other information)

·If you are using other drugs, please consult your physician or pharmacist before using this product.

·Shielded from light, sealed, stored at room temperature.

Inactive Ingredients (Inactive ingredients)

Petrolatum,Mineral Oil,Ozokerite,Far-Infrared Ceramic Powder,Cera Microcristallina,Stearyl Alcohol,Glyceryl Stearate,Hypericum Perforatum Oil,Camphor,Sucrose Acetate Isobutyrate,Vanillyl Butyl Ether,Cetyl Alcohol,Euphorbia Cerifera (Candelilla) Wax,Hydroxystearic Acid,Water,Butylene Glycol,Citrus Reticulata (Tangerine) Fruit Extract,Glycerin,Fucus Vesiculosus Extract,1,2-Hexanediol,Hydroxyacetophenone

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

In case of accidental ingestion, get medical help or contact a poison control center immediately.


Advanced Ingredient Data


Raw Label Data

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