CANESPIES- tolnaftate cream 
OPMX LLC

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.

----------

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.

Keep out of reach of children

WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES.

DIRECTIONS

INACTIVE INGREDIENTS

CETYL ALCOHOL, LIQUID PARAFFIN, METHYLPARABEN, POLYOXYETHYLNE CETYLETHER, PROPYLENE GLYCOL, PROPYLPARABEN, PURIFIED WATER, SORBITAN MONOSTEARATE, STEARYL ALCOHOL

OTHER INFORMATION

0-LBL_Canespies Cream USP 1pct 0.5 oz

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
CETYL ALCOHOL (UNII: 936JST6JCN)  
MINERAL OIL (UNII: T5L8T28FGP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CETETH-10 (UNII: LF9X1PN3XJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
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 finalpart333C07/26/2022
Labeler - OPMX LLC (029918743)

Revised: 7/2022
Document Id: d9f93da9-b53e-2b5f-e053-2a95a90a1fb3
Set id: e2f9eedc-3c43-416b-85b5-ba07fb5fb4db
Version: 3
Effective Time: 20220726
 
OPMX LLC