OTC Medication Information: Athletes Foot

ATHLETES FOOT- tolnaftate solution/ drops
Imperial Feet B.V.

Active Ingredient

Tolnaftate 1%

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.

Ask a doctor

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

Stop Use

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

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

Other Information

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

Purpose

Antifungal

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.

Keep out of reach of children

Supervise children in the use of this product

Use

Cures most Athlete’s Foot

Principal Display Panel / Product Label

PDP
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ATHLETES FOOT
tolnaftate solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:83837-002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE 1 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
CALENDULA OFFICINALIS FLOWER 0.3 g in 100 mL
CHLORPHENESIN 0.2 g in 100 mL
PIROCTONE OLAMINE 0.05 g in 100 mL
ALMOND OIL 1 g in 100 mL
POLYOXYL 40 HYDROGENATED CASTOR OIL 13 g in 100 mL
WATER 0.3 g in 100 mL
SQUALENE 0.1 g in 100 mL
METHYL GLUCETH-20 3 g in 100 mL
.ALPHA.-BISABOLOL, (+)- 0.1 g in 100 mL
PHENOXYETHANOL 0.75 g in 100 mL
POLYSORBATE 20 0.1 g in 100 mL
CHAMOMILE FLOWER OIL 0.3 g in 100 mL
POLYETHYLENE GLYCOL 400 70 mL in 100 mL
GLYCERIN 0.3 g in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:83837-002-01 75 mL in 1 BOTTLE, DROPPER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M005 02/19/2024
Labeler — Imperial Feet B.V. (386790021)
Registrant — Creative Essences Inc (079120182)
Establishment
Name Address ID/FEI Operations
Creative Essences Inc 079120182 manufacture (83837-002)

Revised: 02/2024 Imperial Feet B.V.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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