83818-017 Update Manufacturer

83818-017 Update Manufacturer
SPL v3
SPL
SPL Set ID 3a077685-4177-bc0d-e063-6294a90a461b
Route
TOPICAL
Published
Effective Date 2025-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Lavender Oil Calendula Arvensis Whole Glycerin Witch Hazel Aloe Vera Leaf Water Tea Tree Oil Dimethicone Cetearyl Alcohol Caprylic/capric Triglyceride Phenoxyethanol Ethylhexylglycerin Vitamin E Polyethylene Glycol Succinate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-16

Description

Clotrimazole 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Clotrimazole 1%

Use

■ Treats and relieves:

- Athlete's foot (tinea pedis) - Jock itch (tinea cruris) - Ringworm (tinea corporis)

■ Reduces itching, redness, and discomfort caused by fungi.

Stop Use

if irritation develops or condition worsens

Warnings

For external use only

Questions

Email us: [email protected]

Ask Doctor

if irritation develops or condition worsens

Directions

■ Clean and dry affected area thoroughly

■ Apply a thin layer twice daily (morning & night)

■ Use for 2-4 weeks for full effect. Wash hands after use

Do Not Use

on broken skin or for vaginal yeast infections

When Using

avoid contact with eyes

Active Ingredient

Clotrimazole 1%

Other Information

■ Store at 20-25°C (68-77°F)

■ Avoid direct sunlight and heat

Inactive Ingredients

Water, Aloe Vera Leaf Extract, Tea Tree Oil, Lavender Oil, Calendula Extract, Witch Hazel Extract, Dimethicone, Cetearyl Alcohol, Caprylic/Capric Triglyceride, Glycerin, Phenoxyethanol, Ethylhexylglycerin, Vitamin E

Principal Display Panel

Keep Out of Reach of Children

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


Structured Label Content

Use

■ Treats and relieves:

- Athlete's foot (tinea pedis) - Jock itch (tinea cruris) - Ringworm (tinea corporis)

■ Reduces itching, redness, and discomfort caused by fungi.

Purpose

Antifungal

Stop Use

if irritation develops or condition worsens

Warnings

For external use only

Questions

Email us: [email protected]

Ask Doctor

if irritation develops or condition worsens

Directions

■ Clean and dry affected area thoroughly

■ Apply a thin layer twice daily (morning & night)

■ Use for 2-4 weeks for full effect. Wash hands after use

Do Not Use (Do not use)

on broken skin or for vaginal yeast infections

When Using

avoid contact with eyes

Active Ingredient

Clotrimazole 1%

Other Information (Other information)

■ Store at 20-25°C (68-77°F)

■ Avoid direct sunlight and heat

Inactive Ingredients (Inactive ingredients)

Water, Aloe Vera Leaf Extract, Tea Tree Oil, Lavender Oil, Calendula Extract, Witch Hazel Extract, Dimethicone, Cetearyl Alcohol, Caprylic/Capric Triglyceride, Glycerin, Phenoxyethanol, Ethylhexylglycerin, Vitamin E

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.


Advanced Ingredient Data


Raw Label Data

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