CANESPIES- tolnaftate cream 
OPMX LLC

----------

ACTIVE INGREDIENTS

TOLNAFTATE 1%

PURPOSE

ANTIFUNGAL

USES

WARNINGS

For external use only.

STOP USE AND ASK A DOCTOR IF

IRRITATION OCCURS

THERE IS NO IMPROVEMENT WITHIN 4 WEEKS.

DO NOT USE ON CHILDREN UNDER 2 YEARS OF AGE EXCEPT UNDER THE ADVICE AND SUPERVISION OF A DOCTOR.

WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES.

Keep out of reach of children

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

CETETH-20, CETYL ALCOHOL, CHLOROCRESOL, MINERAL OIL, PROPYLENE GLYCOL, SODIUM PHOSPHATE MONOBASIC, WHITE SOFT PARAFFIN, PURIFIED WATER

NDC 69729-610-05

CC1CC2

CANESPIES 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-610
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
MINERAL OIL (UNII: T5L8T28FGP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
CETETH-20 (UNII: I835H2IHHX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
CHLOROCRESOL (UNII: 36W53O7109)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69729-610-051 in 1 BOX07/26/2022
1NDC:69729-610-0114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00507/26/2022
Labeler - OPMX LLC (029918743)

Revised: 5/2024
Document Id: 18af4a4a-82b5-da15-e063-6394a90a56da
Set id: e2f9eedc-3c43-416b-85b5-ba07fb5fb4db
Version: 4
Effective Time: 20240517
 
OPMX LLC