CANESPIES- tolnaftate cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
TOLNAFTATE 1%
Available from:
HEALTH LIFE
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
ANTIFUNGAL - 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
Authorization status:
OTC monograph final
Authorization number:
69517-610-01, 69517-610-05

CANESPIES- tolnaftate cream

HEALTH LIFE

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.

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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

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

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

CANESPIES

tolnaftate cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 517-6 10

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

TO LNAFTATE (UNII: 0 6 KB6 29 TKV) (TOLNAFTATE - UNII:0 6 KB6 29 TKV)

TOLNAFTATE

1 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

HEALTH LIFE

MINERAL O IL (UNII: T5L8 T28 FGP)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

CETETH-10 (UNII: LF9 X1PN3XJ)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

WATER (UNII: 0 59 QF0 KO0 R)

SO RBITAN MO NO STEARATE (UNII: NVZ4I0 H58 X)

STEARYL ALCO HO L (UNII: 2KR8 9 I4H1Y)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 517-6 10 -0 5

1 in 1 BOX

0 4/0 1/20 19

1

NDC:6 9 517-6 10 -0 1

14 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt333C

0 9 /0 5/20 18

Labeler -

HEALT H LIFE (079656178)

Revised: 4/2019

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