TM-TOLNAFTATE LR- tolnaftate 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 ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

Warnings

• For external use only
Do Not Use– On children under 2 years of age 
When using this product, do not get into eyes
Stop use and ask a doctor

Directions

Other information

Inactive ingredients

a-Bisabalol, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetearyl Alcohol, Curcuma Longa (Turmeric) Extract, Dimethyl Isosorbide, Ethylhexylglycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Hydroxyethyl Acrylate/Sodium AcryloyldimethylTaurate Copolymer, Isohexadecane, Isopropyl Alcohol, Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Polysorbate
60, Sodium Hydroxide, Thymus Vulgaris (Thyme) Extract, Zingiber Officinalis (Ginger) Extract.

Product label

image description

TM-TOLNAFTATE LR 
tolnaftate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83035-1262
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
BISABOLOL OXIDE A (UNII: 16AE65F94Y)  
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
TURMERIC (UNII: 856YO1Z64F)  
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
THYME (UNII: CW657OBU4N)  
GINGER (UNII: C5529G5JPQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83035-1262-41 in 1 CARTON06/26/2023
145 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C06/01/2023
Labeler - Singular Dreamer Ltd.dba True Marker (129504103)
Registrant - Singular Dreamer Ltd.dba True Marker (129504103)

Revised: 6/2023
Document Id: fea3f313-ad83-0e09-e053-6394a90a6029
Set id: d67267eb-45b5-438f-b16c-9e1ee5230360
Version: 1
Effective Time: 20230621
 
Singular Dreamer Ltd.dba True Marker