Update-85398-017-01

Update-85398-017-01
SPL v3
SPL
SPL Set ID 4141cca0-1650-6e00-e063-6394a90a13e3
Route
TOPICAL
Published
Effective Date 2025-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (0.6 g)
Inactive Ingredients
Aloe Barbadensis Leaf Juice Propylene Glycol Glyceryl Stearate Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Alcohol Potassium Alum Glycerin Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Polysorbate 80 Allantoin Isohexadecane Dimethicone 6 Ethylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-31

Description

Tolnaftate 1%


Medication Information

Warnings and Precautions

FOR EXTERNAL USE ONLY

Indications and Usage
  • adults and children 12 years and over
  • use the tip of the cap to break the seal and open the tube
  • wash the affected skin with soap and water and dry completely before applying
  • for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily
  • between the toesonly: apply twice a day(morning and night) for 1week or as directed by a doctor
  • on the bottomor sides of the foot: apply twice a day(morningand night)for 2 weeks or as directed by a doctor
  • for jock itch and ringworm: apply once a day(morning or night) for 1 week or as directed by adoctor
  • wash hands after each use
  • children under 12 years: ask a doctor
Dosage and Administration
  • cures most athlete's foot (tinea pedis)
  • cures most jock itch (tinea crurs) and ringworm(tinea corporis)
  • relieves itching, burning, cracking and scaling which accompany these conditions
Description

Tolnaftate 1%

Section 50565-1

lf swallowed, call a poison control centre or get medical help right away.

Section 50567-7

do not get into eyes. lf eye contact occurs, rinse thoroughly with water

Section 50569-3

if too much irritationo ccurs or gets worse

Section 50570-1
  • on nails or scalp
  • in or near themouth or eyes
  • for vaginal yeast infections
Section 51727-6

Allantoin, Glycerin, Propylene Glycol, PCA Dimethicone, Ethylparaben, Glyceryl Stearate, Primary Alcohol, Ethoxylate,Alumen, Sodium Acrylate/Sodium, Acryloyldimethyl Taurate Copolymer, lsohexadecane,Polysorbate 80, Aloe Barbadensis Leaf Juice

Section 51945-4

Section 53413-1
Section 55105-1

Antifungal

Section 55106-9

Tolnaftate 1%

Section 60561-8
  • Do not use if seal on tube is broken or is not visible.
  • Store at 68-77°F(20-25°C)

Structured Label Content

Indications and Usage (34067-9)
  • adults and children 12 years and over
  • use the tip of the cap to break the seal and open the tube
  • wash the affected skin with soap and water and dry completely before applying
  • for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily
  • between the toesonly: apply twice a day(morning and night) for 1week or as directed by a doctor
  • on the bottomor sides of the foot: apply twice a day(morningand night)for 2 weeks or as directed by a doctor
  • for jock itch and ringworm: apply once a day(morning or night) for 1 week or as directed by adoctor
  • wash hands after each use
  • children under 12 years: ask a doctor
Dosage and Administration (34068-7)
  • cures most athlete's foot (tinea pedis)
  • cures most jock itch (tinea crurs) and ringworm(tinea corporis)
  • relieves itching, burning, cracking and scaling which accompany these conditions
Warnings and Precautions (34071-1)

FOR EXTERNAL USE ONLY

Section 50565-1 (50565-1)

lf swallowed, call a poison control centre or get medical help right away.

Section 50567-7 (50567-7)

do not get into eyes. lf eye contact occurs, rinse thoroughly with water

Section 50569-3 (50569-3)

if too much irritationo ccurs or gets worse

Section 50570-1 (50570-1)
  • on nails or scalp
  • in or near themouth or eyes
  • for vaginal yeast infections
Section 51727-6 (51727-6)

Allantoin, Glycerin, Propylene Glycol, PCA Dimethicone, Ethylparaben, Glyceryl Stearate, Primary Alcohol, Ethoxylate,Alumen, Sodium Acrylate/Sodium, Acryloyldimethyl Taurate Copolymer, lsohexadecane,Polysorbate 80, Aloe Barbadensis Leaf Juice

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)
Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

Tolnaftate 1%

Section 60561-8 (60561-8)
  • Do not use if seal on tube is broken or is not visible.
  • Store at 68-77°F(20-25°C)

Advanced Ingredient Data


Raw Label Data

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