tolnaftate antifungal cream 1%

tolnaftate antifungal cream 1%
SPL v2
SPL
SPL Set ID 2b2303dd-fec2-4ff4-a0ae-6bfb921dd246
Route
topical
Published
Effective Date 2018-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
tolnaftate (1 g)
Inactive Ingredients
butylated hydroxytoluene polyethylene glycol 400 polyethylene glycol 3350 titanium dioxide petrolatum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph final active Since 1995-01-01

Purpose

Antifungal

How Supplied

Product: 76413-321 NDC: 76413-321-15 15 g in a TUBE

Description

Drug Facts


Medication Information

Warnings

For external use only

Uses
  • proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • helps prevent most athlete's foot with daily use
  • for effective relief of itching, burning and cracking
Purpose

Antifungal

Directions
  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
  • use daily for 4 weeks; if condition persists longer, ask a doctor
  • to prevent athlete's foot, apply once or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails
Other Information
  • store between 20° to 25°C (68° to 77°F)
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredients

BHT, PEG-400, PEG-3350, titanium dioxide, white petrolatum

How Supplied

Product: 76413-321

NDC: 76413-321-15 15 g in a TUBE

Description

Drug Facts

Questions?

Call 1-866-923-4914

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks
Section 50567-7

When using this product avoid contact with eyes

Section 50570-1

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

Active Ingredient

Tolnaftate 1%

Tolnaftate Antifungal (tolnaftate) Cream

Structured Label Content

Warnings

For external use only

Uses
  • proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • helps prevent most athlete's foot with daily use
  • for effective relief of itching, burning and cracking
Purpose

Antifungal

Directions
  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
  • use daily for 4 weeks; if condition persists longer, ask a doctor
  • to prevent athlete's foot, apply once or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails
Other Information (Other information)
  • store between 20° to 25°C (68° to 77°F)
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

BHT, PEG-400, PEG-3350, titanium dioxide, white petrolatum

How Supplied (HOW SUPPLIED)

Product: 76413-321

NDC: 76413-321-15 15 g in a TUBE

Questions?

Call 1-866-923-4914

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks
Section 50567-7 (50567-7)

When using this product avoid contact with eyes

Section 50570-1 (50570-1)

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

Active Ingredient (Active ingredient)

Tolnaftate 1%

Tolnaftate Antifungal (tolnaftate) Cream (TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM)

Advanced Ingredient Data


Raw Label Data

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