TOLNAFTATE- tolnaftate cream 
NuCare Pharmaceuticals,Inc.

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Drug Facts

Active ingredient

Tolnaftate USP 1%

Purpose

Antifungal

Uses

Warnings

For external use only

Do not use

  • on children under 2 years of age unless directed by a doctor

When using this product avoid contact with eyes

Stop use and ask a doctor if

  • 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

For athlete's foot

For ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.

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

Inactive ingredients

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

Questions?

Adverse Drug Event call (800)616-2471

Dist. By MAJOR PHARMACEUTICALS, 31778 Enterprise Drive, Livonia, MI 48150 USA

Re-Oder No. 100497 M-88 Rev. 9/09 Manufactured in USA

Principal Display Panel –

pdp

TOLNAFTATE 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-4245(NDC:0904-0722)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETETH-20 (UNII: I835H2IHHX)  
CHLOROCRESOL (UNII: 36W53O7109)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68071-4245-514.18 g in 1 TUBE; Type 0: Not a Combination Product01/22/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01402/11/2010
Labeler - NuCare Pharmaceuticals,Inc. (010632300)
Establishment
NameAddressID/FEIBusiness Operations
NuCare Pharmaceuticals,Inc.010632300relabel(68071-4245)

Revised: 6/2024
Document Id: 1a3c5c49-b376-1318-e063-6394a90a47b6
Set id: 63665de7-8415-651f-e053-2991aa0ac2bb
Version: 4
Effective Time: 20240606
 
NuCare Pharmaceuticals,Inc.