TERBINAFINE HCL CICLOPIROX- terbinafine hcl, ciclopirox 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.

----------

ACTIVE:

TERBINAFINE HCL 4%, CICLOPIROX 4%

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-Ciclopirox_LBL_10 mL

TERBINAFINE HCL CICLOPIROX 
terbinafine hcl, ciclopirox solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70414-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TERBINAFINE HYDROCHLORIDE (UNII: 012C11ZU6G) (TERBINAFINE - UNII:G7RIW8S0XP) TERBINAFINE4 g  in 100 mL
CICLOPIROX (UNII: 19W019ZDRJ) (CICLOPIROX - UNII:19W019ZDRJ) CICLOPIROX4 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:70414-111-1110 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: dd732d74-8a09-4bb3-8ca4-2c3545f4ca81
Set id: 49d1b0cd-1e47-4126-8f7d-2da0d0ec68b3
Version: 3
Effective Time: 20180417
 
DR MARC'S MANUFACTURING AND SALES