83818-023 Update Manufacturer

83818-023 Update Manufacturer
SPL v2
SPL
SPL Set ID 3c783061-8e2d-8a84-e063-6394a90a5265
Route
TOPICAL
Published
Effective Date 2025-08-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (7 g)
Inactive Ingredients
Ethylhexylglycerin Cocos Nucifera (coconut) Oil .alpha.-tocopherol Acetate Shea Butter Ascorbyl Palmitate Glycerin Phenoxyethanol Sodium Hydroxide Water Centella Asiatica Triterpenoids Carbomer

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-16

Description

Arnica Montana 7%

Purpose

Bruise, Pain & Swelling Relief


Medication Information

Purpose

Bruise, Pain & Swelling Relief

Description

Arnica Montana 7%

Use

Temporarily relieves: Bruising, Swelling, Minor muscle or joint pain.

Helps reduce skin discoloration and tenderness from

everyday bumps, overuse, or minor injuries.

Stop Use

Rash or irritation occurs;

Symptoms persist for more than 7 days or worsen.

Warnings

For external use only.

Questions

Email us at: [email protected]

Ask Doctor

Rash or irritation occurs;

Symptoms persist for more than 7 days or worsen.

Directions

■ Apply a thin layer to affected area 2–3 times daily.

■ Gently massage until fully absorbed.

■ Use consistently for best results.

■ Wash hands after use.

Do Not Use

to broken skin or open wounds.

When Using

avoid contact with eyes and mucous membranes.

Active Ingredient

Arnica Montana 7%

Other Information

■ Store at 20–25°C (68–77°F)

■ Do not use if safety seal is broken

■ Keep away from direct sunlight and excessive heat

Inactive Ingredients

Water (Aqua), Shea Butter, Coconut Oil (Cocos NuciferaOil), Centella Asiatica Extract, Tocopheryl Acetate

(Vitamin E), Ascorbyl Palmitate (Vitamin C), Glycerin, Carbomer, Phenoxyethanol, Ethylhexylglycerin, Sodium Hydroxide

Principal Display Panel

Keep Out of Reach of Children

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


Structured Label Content

Use

Temporarily relieves: Bruising, Swelling, Minor muscle or joint pain.

Helps reduce skin discoloration and tenderness from

everyday bumps, overuse, or minor injuries.

Purpose

Bruise, Pain & Swelling Relief

Stop Use

Rash or irritation occurs;

Symptoms persist for more than 7 days or worsen.

Warnings

For external use only.

Questions

Email us at: [email protected]

Ask Doctor

Rash or irritation occurs;

Symptoms persist for more than 7 days or worsen.

Directions

■ Apply a thin layer to affected area 2–3 times daily.

■ Gently massage until fully absorbed.

■ Use consistently for best results.

■ Wash hands after use.

Do Not Use (Do not use)

to broken skin or open wounds.

When Using

avoid contact with eyes and mucous membranes.

Active Ingredient

Arnica Montana 7%

Other Information (Other information)

■ Store at 20–25°C (68–77°F)

■ Do not use if safety seal is broken

■ Keep away from direct sunlight and excessive heat

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Shea Butter, Coconut Oil (Cocos NuciferaOil), Centella Asiatica Extract, Tocopheryl Acetate

(Vitamin E), Ascorbyl Palmitate (Vitamin C), Glycerin, Carbomer, Phenoxyethanol, Ethylhexylglycerin, Sodium Hydroxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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

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


Advanced Ingredient Data


Raw Label Data

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