Tolnaftate by Innovida Pharmaeutique Corporation

Tolnaftate by

Drug Labeling and Warnings

Tolnaftate by is a Otc medication manufactured, distributed, or labeled by Innovida Pharmaeutique Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TOLNAFTATE- tolnaftate cream 
Innovida Pharmaeutique Corporation

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Active Ingredient 

Tolnaftate 1%

Purpose

Antifungal

Uses

• Proven 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
This product is not effective on the scalp or nails

When using this productavoid contact with the eyes

Stop use and ask a doctor if Irritation occurs There is no improvement within 4 weeks

Keep out of reach of children
If swallowed, get medical help or contact a Poisen Control Center (1-800-222-1222) right away
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
•  Use daily for 4 weeks; if condition persists longer, ask a doctor
•  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
•  To prevent athlete's foot, apply once or twice daily (morning and/or night)

Other Information

Store between 20° to 25ºC (68º to 77ºF)

Inactive Ingredients

Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Sodium Phosphate Dihydrate, White Soft Paraffin (Petrolatum)

Questions or Comments? 1-888-462-4166

Product label

TOLNAFTATE 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71800-056
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETETH-20 (UNII: I835H2IHHX)
MINERAL OIL (UNII: T5L8T28FGP)
CHLOROCRESOL (UNII: 36W53O7109)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
PETROLATUM (UNII: 4T6H12BN9U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71800-056-09	14.18 g in 1 TUBE; Type 0: Not a Combination Product	02/10/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	02/10/2025	12/31/2025

Labeler - Innovida Pharmaeutique Corporation (080892908)

Revised: 12/2025

Document Id: 46e11f92-8bde-e6e5-e063-6394a90a7bc6

34390-5

Set id: 498197e9-06bc-4eb1-85db-64304f567ba8

Version: 2

Effective Time: 20251226