SPL v1
SPL
SPL Set ID 43427f16-59be-c0ee-e063-6294a90aee63
Route
TOPICAL
Published
Effective Date 2025-10-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Water Acetic Acid Sophora Flavescens Root Stellera Chamaejasme Whole Pseudolarix Amabilis Bark Crocus Sativus Whole Cnidium Seed Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-10-13

Description

Tolnaftate 1%


Medication Information

Warnings and Precautions
  • For external use on nail
  • fungus(onychomycosis) only, pleasedon't use it on healthy nails
  • Don't use it on damaged skin,otherwise, your damaged skin maybe painful.
  • For people with severe skinulceration, please use it with caution.
  • Don't drink, avoid contact with your eye
  • Children use it under thesupervision of adults.
  • This product cannot replacemedicine.
Indications and Usage

For all caused by nail fungus

nail discoloration

nail thickening

nail splitting

nail crumbling

Dosage and Administration

Apply it in the day and night (twice a day)

Description

Tolnaftate 1%

Section 50565-1

Keep out of reach of children.

Section 50566-9

You are allergic to vinegarsuch as itching, rash swelling of thelips, eyelids, and shortness ofbreath

Section 50567-7

fungal infection itching

Section 50568-5

You are allergic to vinegarsuch as itching, rash swelling of thelips, eyelids, and shortness ofbreath

Section 50570-1
  • On damaged skin(cuts, abrasions, eczema, sunburn).
  • If you are allergic to any of the ingredients in this product.
  • If you are pregnant or breastfeeding.
Section 51727-6

Water, Acetic Acid, SophoraFlavescens,Stellera Chamaejasme whole, ChineseGolden Larch Bark, FructusCnidii, Crocus Sativus Whole, Ethanol,Cnidium Seed, Alcohol

Section 51945-4

Section 55105-1

Antifungal Disinfectant Treatment Solution

Section 55106-9

Tolnaftate 1%

Section 59845-8
  • Apply it in the day and night(twice a day).
  • Before using it for the first time.soak the diseased nail withwarm water to soften it, use thenail file to polish the nail, make itthin visibly, and scrape off thedirt on the nail (be careful not tohurt the nail bed), then apply the liquid.
  • After first use, every 2-3 daysuse the nail file to polish thesurface of the diseased nail andthen continue to use it.
  • lf swallowed, get medical helpor contact a poison controlcenter right away.
Section 60561-8
  • Do not use if glued carton end flaps are open or if the tube seal is broken.
  • Store at 68°-77°F (20°-25C).
  • Keep container tightly closed

Structured Label Content

Indications and Usage (34067-9)

For all caused by nail fungus

nail discoloration

nail thickening

nail splitting

nail crumbling

Dosage and Administration (34068-7)

Apply it in the day and night (twice a day)

Warnings and Precautions (34071-1)
  • For external use on nail
  • fungus(onychomycosis) only, pleasedon't use it on healthy nails
  • Don't use it on damaged skin,otherwise, your damaged skin maybe painful.
  • For people with severe skinulceration, please use it with caution.
  • Don't drink, avoid contact with your eye
  • Children use it under thesupervision of adults.
  • This product cannot replacemedicine.
Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

You are allergic to vinegarsuch as itching, rash swelling of thelips, eyelids, and shortness ofbreath

Section 50567-7 (50567-7)

fungal infection itching

Section 50568-5 (50568-5)

You are allergic to vinegarsuch as itching, rash swelling of thelips, eyelids, and shortness ofbreath

Section 50570-1 (50570-1)
  • On damaged skin(cuts, abrasions, eczema, sunburn).
  • If you are allergic to any of the ingredients in this product.
  • If you are pregnant or breastfeeding.
Section 51727-6 (51727-6)

Water, Acetic Acid, SophoraFlavescens,Stellera Chamaejasme whole, ChineseGolden Larch Bark, FructusCnidii, Crocus Sativus Whole, Ethanol,Cnidium Seed, Alcohol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antifungal Disinfectant Treatment Solution

Section 55106-9 (55106-9)

Tolnaftate 1%

Section 59845-8 (59845-8)
  • Apply it in the day and night(twice a day).
  • Before using it for the first time.soak the diseased nail withwarm water to soften it, use thenail file to polish the nail, make itthin visibly, and scrape off thedirt on the nail (be careful not tohurt the nail bed), then apply the liquid.
  • After first use, every 2-3 daysuse the nail file to polish thesurface of the diseased nail andthen continue to use it.
  • lf swallowed, get medical helpor contact a poison controlcenter right away.
Section 60561-8 (60561-8)
  • Do not use if glued carton end flaps are open or if the tube seal is broken.
  • Store at 68°-77°F (20°-25C).
  • Keep container tightly closed

Advanced Ingredient Data


Raw Label Data

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