TERBINAFINE HCL CHLORTIMAZOLE AND TOLNAFTATE- terbinafine hcl, clotrimazole, tolnaftate solution 
DR MARC'S MANUFACTURING AND SALES

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ACTIVE:

TERBINAFINE HCL 1%, CLOTRIMAZOLE 1%, TOLNAFTATE 1%

USE:

FOR TOPICAL APPLICATION TO THE NAIL.

USUAL DOSAGE:

APPLY TWICE DAILY FOR PSORIATIC NAILS, NON MYCOTIC ALLERGIC CONDITIONS.

INACTIVES:

MINERAL OIL, PETROLATUM, ISOPROPYL ALCOHOL, EUCALYPTUS GLOBULUS (EUCALYPTUS) LEAF OIL, MENTHA PIPERITA (PEPPERMINT) OIL, GLYCINE MAX (SOYBEAN) OIL, PROPYLENE GLYCOL, ACETIC ACID, POLYAMINOPROPYL BIGUANIDE, LECITHIN, BETAINE

STORAGE:

STORE AT 20-25°C (68-77°F)

Terbinafine HCl-Chlortimazole-Tolnaftate_LBL_10 mL

TERBINAFINE HCL CHLORTIMAZOLE AND TOLNAFTATE 
terbinafine hcl, clotrimazole, tolnaftate solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70414-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TERBINAFINE HYDROCHLORIDE (UNII: 012C11ZU6G) (TERBINAFINE - UNII:G7RIW8S0XP) TERBINAFINE1 g  in 100 mL
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 mL
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
SOYBEAN OIL (UNII: 241ATL177A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ACETIC ACID (UNII: Q40Q9N063P)  
CAPROLACTONE (UNII: 56RE988L1R)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
BETAINE (UNII: 3SCV180C9W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70414-110-1110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/30/201804/17/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/30/201804/17/2018
Labeler - DR MARC'S MANUFACTURING AND SALES (084006446)

Revised: 4/2018
Document Id: f05050c3-c071-4e51-81a9-ca7416fdf5dc
Set id: f2c75602-e984-475f-a0e9-1e1d8b230e0e
Version: 3
Effective Time: 20180417
 
DR MARC'S MANUFACTURING AND SALES