Athlete's Foot 75 Ml Ndc 83837-002-01

Athlete's Foot 75 Ml Ndc 83837-002-01
SPL v3
SPL
SPL Set ID 1189c7d8-7c8f-ae01-e063-6294a90ac270
Route
TOPICAL
Published
Effective Date 2024-02-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Calendula Officinalis Flower Chlorphenesin Glycerin Piroctone Olamine Almond Oil Polyoxyl 40 Hydrogenated Castor Oil Water Squalene Methyl Gluceth-20 .alpha.-bisabolol, (+)- Phenoxyethanol Polysorbate 20 Chamomile Flower Oil Polyethylene Glycol 400

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-19

Description

Tolnaftate 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Tolnaftate 1%

Use

Cures most Athlete's Foot

Stop Use

If irritation occurs or there is no improvement within 4 weeks, discontinue use and consult a doctor.

Warnings

. Do not use on children under 2 years of age unless directed by a doctor.

. For external use only.

. Avoid contact with the eyes.

. If irritation occurs or there is no improvement within 4 weeks, discontinue use and consult a doctor.

Directions
  • Wash the affected area and dry thoroughly.
  • Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.
  • Supervise children in the use of this product.
  • Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
  • If condition persists longer, consult a doctor.
Ask A Doctor

If irritation occurs or there is no improvement within 4 weeks, discontinue use and consult a doctor.

Active Ingredient

Tolnaftate 1%

Other Information

Store between 20 C and 30 C (68 F and 86 F)

Inactive Ingredient

Inactive Ingredients Almond Oil, Alpha-Bisabolene,

Calendula Officinalis Flower, Chamomile, Chlorphenesin,

Glycerin, Methyl-Gluceth-20, Phenoxyethanol, Piroctone

Olamine, Polysorbate 20, Polyethylene Glycol 400,

Polyoxyl 40 Hydrogenated Castor Oil, Squalene, Water

Keep Out of Reach of Children

Supervise children in the use of this product

Principal Display Panel / Product Label


Structured Label Content

Use

Cures most Athlete's Foot

Purpose

Antifungal

Stop Use

If irritation occurs or there is no improvement within 4 weeks, discontinue use and consult a doctor.

Warnings

. Do not use on children under 2 years of age unless directed by a doctor.

. For external use only.

. Avoid contact with the eyes.

. If irritation occurs or there is no improvement within 4 weeks, discontinue use and consult a doctor.

Directions
  • Wash the affected area and dry thoroughly.
  • Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.
  • Supervise children in the use of this product.
  • Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
  • If condition persists longer, consult a doctor.
Ask A Doctor (Ask a doctor)

If irritation occurs or there is no improvement within 4 weeks, discontinue use and consult a doctor.

Active Ingredient

Tolnaftate 1%

Other Information

Store between 20 C and 30 C (68 F and 86 F)

Inactive Ingredient

Inactive Ingredients Almond Oil, Alpha-Bisabolene,

Calendula Officinalis Flower, Chamomile, Chlorphenesin,

Glycerin, Methyl-Gluceth-20, Phenoxyethanol, Piroctone

Olamine, Polysorbate 20, Polyethylene Glycol 400,

Polyoxyl 40 Hydrogenated Castor Oil, Squalene, Water

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

Supervise children in the use of this product

Principal Display Panel / Product Label


Advanced Ingredient Data


Raw Label Data

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