Tolnaftate: Package Insert and Label Information

TOLNAFTATE- tolnaftate cream
Cardinal Health 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 USP 1%

Purpose

Antifungal Cream

Uses

  • Cures most athlete’s foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis).
  • Relieves the itching, irratation, redness, scaling and discomfort which can accompany these conditions.

Warnings

  • Do not use on children under 2 years of age unless directed by a doctor.
  • For external use only avoid contact with eyes.
  • Irritation occurs or if there is no improvement within 4 weeks (for athlete’s foot and ringworm)irritation occurs or if there is no improvement within 2 weeks (for jock itch).

Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

  • Clean the affected area and dry thoroughly.
  • Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor.
  • Supervise children in the use of this product.

For athlete’s foot

  • Pay special attention to the spaces between the toes.
  • Wear well fitting ventilated shoes.
  • Change shoes and socks at least once daily.
  • For athlete’s foot and ringworm, use daily for 4 weeks.
  • For jock itch, use daily for 2 weeks.
  • If condition persists longer, consult a doctor.
  • This product is not effective on the scalp or nails.

Other information

  • Store at controlled room temperature 15°-30°C (59°-86°F).
  • Close cap tighty after ever use.

Inactive ingredients

Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, White Petrolatum, Propylene Glycol, Sodium Phosphate Monobasic, Water

Questions?

1-800-222-1222

Principal Display Panel – 1.0 oz Tube

LEADER NDC 70000-0494-1

Compare to Tinactin

Antifungal Cream (Tolnaftate 1%)

CURES Most:

ATHLETE’S FOOT

Net Wt. 1.0 OZ (28 g)

Principal Display Panel – 1.0 oz Tube
(click image for full-size original)

Principal Display Panel – 1.0 oz Carton

Principal Display Panel – 1.0 oz Carton
(click image for full-size original)

LEADER NDC 70000-0494-1

Antifungal Cream (Tolnaftate 1%)

CURES Most:

ATHLETE’S FOOT

Net Wt. 1.0 OZ (28 g)

Principal Display Panel – 1.0 oz Carton
(click image for full-size original)
TOLNAFTATE
tolnaftate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0494
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
CETOSTEARYL ALCOHOL
CETETH-20
CHLOROCRESOL
MINERAL OIL
PETROLATUM
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS
PROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70000-0494-1 1 TUBE in 1 CARTON contains a TUBE
1 28 g in 1 TUBE This package is contained within the CARTON (70000-0494-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 05/15/2019
Labeler — Cardinal Health LLC (097537435)
Registrant — Sheffield Pharmaceuticals LLC (151177797)
Establishment
Name Address ID/FEI Operations
Sheffield Pharmaceuticals LLC 151177797 MANUFACTURE (70000-0494)

Revised: 01/2021 Cardinal Health LLC

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

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