CANESPIES- tolnaftate cream

CANESPIES by

Drug Labeling and Warnings

CANESPIES by is a Otc medication manufactured, distributed, or labeled by OPMX LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

TOLNAFTATE 1%

PURPOSE

ANTIFUNGAL

USES

• PROVEN CLINICALLY EFFECTIVE IN THE TREATMENT OF ATHLETE'S FOOT (TINEA PEDIS), JOCK ITCH (TINEA CRURIS), RINGWORM (TINEA CORPORIS)
• PROVEN EFFECTIVE IN THE PREVENTION OF ATHLETE'S FOOT
• EFFECTIVELY SOOTHES AND RELIEVES ITCHING ASSOCIATED WITH JOCK ITCH, SCALY SKIN BETWEEN THE TOES AND BURNING FEET

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

Keep out of reach of children

• If swallowed get medical help or contact Poison Control Center right away.

WHEN USING

WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES.

DIRECTIONS

• WASH AFFECTED AREA AND DRY THOROUGHLY
• APPLY A THIN LAYER OVER AFFECTED AREA TWICE DAILY (MORNING AND NIGHT) OR AS DIRECTED BY A DOCTOR
• SUPERVISE CHILDREN IN THE USE OF THIS PRODUCT FOR ATHLETE'S FOOT, PAY SPECIAL ATTENTION TO SPACES BETWEEN THE TOES, WEAR WELL-FITTING, VENTILLATED SHOES AND CHANGE SHOES AND SOCKS AT LEAST ONCE DAILY
• FOR ATHLETE'S FOOT, AND RINGWORM USE DAILY FOR 4 WEEKS, FOR JOCK ITCH USE DAILY FOR 2 WEKS. IF CONDITION PERSISTS LONGER CONSULT A DOCTOR
• THIS PRODUCT IS NOT EFFECTIVE ON THE SCALP OR NAILS

INACTIVE INGREDIENTS

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

OTHER INFORMATION

• STORE AT 15° TO 30°C (59°F TO 86°F)
• LOT NO. & EXP. DATE: SEE BOX OR CRIMP OF TUBE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CANESPIES 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69729-610
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69729-610-05	1 in 1 BOX	09/05/2018
1	NDC: 69729-610-01	14 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	09/05/2018

Labeler - OPMX LLC (029918743)