TM -TOLNAFTATE- tolnaftate 1% liquid 
Singular Dreamer, Ltd dba True Marker

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.

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Active ingredients

Tolnaftate 1%

Purpose

Topical Antifungal

Uses

Warnings

Directions

Other information

Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

Helianthus Annuus (Sunflower) Oil, Vitis Vinifera (Grape) Seed Oil, Mentha Piperita (Peppermint) Oil, Tocopheryl Acetate (Vitamin E), BHT (Butylated hydroxytoluene)

Questions?

304-742-2433

Product label

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TM -TOLNAFTATE 
tolnaftate 1% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83035-1260
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
VITIS VINIFERA FRUIT OIL (UNII: YQ5Q4Y2Z8U)  
PEPPERMINT (UNII: V95R5KMY2B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83035-1260-31 in 1 CARTON03/28/2023
130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
2NDC:83035-1260-445 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/10/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C03/28/2023
Labeler - Singular Dreamer, Ltd dba True Marker (129504103)
Registrant - Singular Dreamer, Ltd dba True Marker (129504103)

Revised: 8/2023
Document Id: 02a7c7a7-9adc-0575-e063-6294a90aadb1
Set id: 964ff52d-fd2a-47b4-bdc5-6a3ef2fc40bc
Version: 4
Effective Time: 20230811
 
Singular Dreamer, Ltd dba True Marker