Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 40498493-2176-4ab5-8966-8119a44d3293
Route
TOPICAL
Published
Effective Date 2017-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1.0 g)
Inactive Ingredients
Cottonseed Oil Honey Jojoba Oil Magnesium Oxide Peppermint Oil Silver Oxide Tea Tree Oil White Wax Zinc Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-06-01

Description

Clotrimazole 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Clotrimazole 1%

Uses

Cures most fungal skin infections, including ringworm and tinea. For effective relief of itching, scaling, cracking, burning, discoloration, soreness, irritation, discomfort, redness and chafing associated with fungal skin infections.

Warnings

For external use only. Do not use on children under two years of age unless directed by a physician. When using this product avoid contact with the eyes. Stop use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks.

Directions

Clean and dry affected skin. Apply a thin layer of ointment over the affected area twice daily (morning and night) or as directed by a doctor.

Active Ingredient

Clotrimazole 1%

Inactive Ingredients

Beeswax, Cottonseed Oil, Jojoba Seed Oil, Magnesium Oxide, Manuka Honey, Peppermint Oil, Silver Oxide, Tea Tree Oil, Zinc Oxide

Keep Out of Reach of Children.

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

Principal Display Panel 50g Tube

Fastrin

Anti - Fungal

Skin Care Ointment

Net WT 50g (1.76 oz.)


Structured Label Content

Uses

Cures most fungal skin infections, including ringworm and tinea. For effective relief of itching, scaling, cracking, burning, discoloration, soreness, irritation, discomfort, redness and chafing associated with fungal skin infections.

Purpose

Antifungal

Warnings

For external use only. Do not use on children under two years of age unless directed by a physician. When using this product avoid contact with the eyes. Stop use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks.

Directions

Clean and dry affected skin. Apply a thin layer of ointment over the affected area twice daily (morning and night) or as directed by a doctor.

Active Ingredient

Clotrimazole 1%

Inactive Ingredients

Beeswax, Cottonseed Oil, Jojoba Seed Oil, Magnesium Oxide, Manuka Honey, Peppermint Oil, Silver Oxide, Tea Tree Oil, Zinc Oxide

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Principal Display Panel 50g Tube (PRINCIPAL DISPLAY PANEL - 50g Tube)

Fastrin

Anti - Fungal

Skin Care Ointment

Net WT 50g (1.76 oz.)


Advanced Ingredient Data


Raw Label Data

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