Proclearz Laser Spray Antifungal

Proclearz Laser Spray Antifungal
SPL v3
SPL
SPL Set ID 53648135-7b79-4775-993b-48fa1298b747
Route
TOPICAL
Published
Effective Date 2024-10-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (10 mg)
Inactive Ingredients
Butylated Hydroxytoluene Isobutane Ppg-12-buteth-16 Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-01

Description

Tolnaftate 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Tolnaftate 1%

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
Warnings

For external use only.

Flammable:Do not use while smoking or near heat or flame

Directions
  • wash affected area and dry thoroughly
  • shake can well and spray 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 changes 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
Do Not Use

on children under 2 years of age unless directed by a doctor.

Drug Facts

Active Ingredient

Tolnaftate 1%

Other Information

store between 20° to 25°C (68° to 77°F)

Package Labeling:

Inactive Ingredients

butylated hydroxytoluene, isobutane, PPG-12-buteth-16, SD alcohol 40-B (30% v/v)

Questions Or Comments?

www.rooftopch.com [email protected]

When Using This Product
  • Avoid contact with eyes
  • Use only as directed. Intentional misuse by deliberately concetrating and inhaling contents can be harmful or fatal
  • Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F
Stop Use and Ask Doctor If
  • irritation occurs
  • there is no improvement within 4 weeks
Keep Out of Reach of Children.

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


Structured Label Content

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

Warnings

For external use only.

Flammable:Do not use while smoking or near heat or flame

Directions
  • wash affected area and dry thoroughly
  • shake can well and spray 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 changes 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
Do Not Use (Do not use)

on children under 2 years of age unless directed by a doctor.

Drug Facts

Active Ingredient (Active ingredient)

Tolnaftate 1%

Other Information (Other information)

store between 20° to 25°C (68° to 77°F)

Package Labeling:

Inactive Ingredients (Inactive ingredients)

butylated hydroxytoluene, isobutane, PPG-12-buteth-16, SD alcohol 40-B (30% v/v)

Questions Or Comments? (Questions or comments?)

www.rooftopch.com [email protected]

When Using This Product (When using this product)
  • Avoid contact with eyes
  • Use only as directed. Intentional misuse by deliberately concetrating and inhaling contents can be harmful or fatal
  • Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F
Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • irritation occurs
  • there is no improvement within 4 weeks
Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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