OTC Medication Information: Tolnaftate Cream 1% ANTIFUNGAL

TOLNAFTATE CREAM 1% ANTIFUNGAL- tolnaftate cream
Trifecta Pharmaceuticals USA, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Anti-Fungal

Uses

● proven clinically effective in the treatment of most athlete’s foot (tinea pedis), and ringworm (tinea corporis) ● helps prevent most athlete’s foot with daily use ● for effective relief of itching, burning and cracking.

Warnings

For external use only.

When using this product avoid contact with the eyes.

Stop use and ask a healthcare professional if ● irritation occurs ● there is no improvement within 4 weeks improvement

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

Directions

● wash affected area and dry thoroughly

● apply a thin layer over affected area twice daily (morning and night)

● supervise children in the use of this product

● for athlete’s foot: pay special attention to spaces between the toes, wear well-fitting ventilated shoes and change shoes and socks at least once daily.

● use daily for 4 weeks; if conditions persists longer, ask a doctor.

● to prevent athlete’s foot, apply once or twice daily (morning and/or night)

● this product is not effective on the scalp or nails.

Inactive ingredients

Cetyl alcohol, ethylparaben, glycerol, light mineral oil, glycerol monostearate, petrolatum, purified water, sodium dodecyl sulfate

Other information

● store between 20° to 25°C ( 68° to 77°F) ● Lot No & Expiration Date: See box or crimp of tube.

DISTRIBUTED BY: MIDWOOD BRANDS, LLC.

500 VOLVO PARKWAY, CHESAPEAKE, VA. 23320

NOT SATISFIED?

Return package and unused product within 30 days to any Family Dollar store for a refund (with receipt) or exchange.

This product is not manufactured or distributed by Bayer, owner of the registered trademark Tinactin®

family wellness tolnaftate 05oz.
(click image for full-size original)

TOLNAFTATE CREAM 1% ANTIFUNGAL
family wellness tolnaftate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69396-042
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE 1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ETHYLPARABEN
GLYCERIN
LIGHT MINERAL OIL
GLYCERYL MONOSTEARATE
PETROLATUM
WATER
SODIUM DODECYLBENZENESULFONATE
CETYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69396-042-05 1 TUBE in 1 BOX contains a TUBE
1 15 g in 1 TUBE This package is contained within the BOX (69396-042-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 08/30/2019
Labeler — Trifecta Pharmaceuticals USA, LLC (079424163)

Revised: 01/2021 Trifecta Pharmaceuticals USA, LLC

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.

Medication Sections

Medication Information by RSS

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.

Terms of Use | Copyright © 2021. All Rights Reserved.