SPL v9
SPL
SPL Set ID 273eb424-5dc3-40c8-9ea7-2f732cbd11c9
Route
TOPICAL
Published
Effective Date 2020-01-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (140 mg)
Inactive Ingredients
Mineral Oil Safflower Oil Jojoba Oil Oregano Leaf Oil .alpha.-tocopherol Acetate Butylated Hydroxytoluene Butylated Hydroxyanisole Phenoxyethanol Methylparaben Ethylparaben Propylparaben Isobutylparaben Butylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-09-19

Description

Drug facts Active Ingredient TOLNAFTATE 1%

Purpose

Purpose Antifungal


Medication Information

Purpose

Purpose

Antifungal

Description

Drug facts Active Ingredient TOLNAFTATE 1%

Warnings

Warnings

  • Do not use
  • on children under 2 years of age unless directed by a physician
  • in or near mouth or eyes
  • for vaginal yeast infections
  • For external use only

Directions

Directions

  • Wash the affected ares with soap and water and dry thoroughly. Apply a thin layer over affected area twice daily (morning and night) or as directed by a physician.
  • 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.
  • For athlete's foot and ringworm, use daily for 4 weeks.
  • For jock itch, use daily for 2 weeks. If condition persists longer, consult a physician.
  • wash hands after each use.

Questions?

Questions?

Call (800)307-8818, Monday through Friday, 8:00 AM to 5:00 PM (Pacific Time).

Indications

Indications

  • Cures most athlete's foot (tinea pedis).
  • Cures most jock itch (tinea cruris) and ring worm (tinea corporis).
  • Relieves itching, cracking, burning, and scaling which accompany these conditions.
  • Prevents most athlete's foot (tinea pedis) with daily use.

Other Information

Other Information

  • Store at room temperature.

Active Ingredients

Drug facts

Active Ingredient

TOLNAFTATE 1%

Inactive Ingredients

Inactive Ingredients

Paraffnum Liquidum, Carthamus Tinctorius (Safflower) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Oreganum Vulgaris (Oregano) Leaf Oil, Tocopheryl acetate, BHT, BHA, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Isobutylpapaben.

When Using This Product

When using this product avoid contact with the eyes. If eye contact occurs, rinse thoroughly with water.

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.

Stop Use and Consult A Physician

Stop use and ask a physician if irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch).

Package Label Tineacide Solution Physician Formula

Blaine Labs

TINEACIDE SOLUTION PHYSICIAN FORMULA

Antifungal Treatment

Dispensed Only by Physicians

NDC: 63347-511-03

15ml (1/2 oz.)

Proudly Made in the USA

Please Recycle! This package is made from recyclable materials.

Exp. / Lot #

Patent Pending

Blaine Labs

Manufactured by

Blaine Labs, Inc

11037 Lockport Place

Sante Fe Springs, CA 90670

27000-P-BX Rev. 20120921

res


Structured Label Content

Purpose

Purpose

Antifungal

Warnings

Warnings

  • Do not use
  • on children under 2 years of age unless directed by a physician
  • in or near mouth or eyes
  • for vaginal yeast infections
  • For external use only

Directions

Directions

  • Wash the affected ares with soap and water and dry thoroughly. Apply a thin layer over affected area twice daily (morning and night) or as directed by a physician.
  • 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.
  • For athlete's foot and ringworm, use daily for 4 weeks.
  • For jock itch, use daily for 2 weeks. If condition persists longer, consult a physician.
  • wash hands after each use.

Questions?

Questions?

Call (800)307-8818, Monday through Friday, 8:00 AM to 5:00 PM (Pacific Time).

Indications

Indications

  • Cures most athlete's foot (tinea pedis).
  • Cures most jock itch (tinea cruris) and ring worm (tinea corporis).
  • Relieves itching, cracking, burning, and scaling which accompany these conditions.
  • Prevents most athlete's foot (tinea pedis) with daily use.

Other Information

Other Information

  • Store at room temperature.

Active Ingredients

Drug facts

Active Ingredient

TOLNAFTATE 1%

Inactive Ingredients

Inactive Ingredients

Paraffnum Liquidum, Carthamus Tinctorius (Safflower) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Oreganum Vulgaris (Oregano) Leaf Oil, Tocopheryl acetate, BHT, BHA, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Isobutylpapaben.

When Using This Product

When using this product avoid contact with the eyes. If eye contact occurs, rinse thoroughly with water.

Keep Out of Reach of Children (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.

Stop Use and Consult A Physician (Stop Use And Consult A Physician)

Stop use and ask a physician if irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch).

Package Label Tineacide Solution Physician Formula

Blaine Labs

TINEACIDE SOLUTION PHYSICIAN FORMULA

Antifungal Treatment

Dispensed Only by Physicians

NDC: 63347-511-03

15ml (1/2 oz.)

Proudly Made in the USA

Please Recycle! This package is made from recyclable materials.

Exp. / Lot #

Patent Pending

Blaine Labs

Manufactured by

Blaine Labs, Inc

11037 Lockport Place

Sante Fe Springs, CA 90670

27000-P-BX Rev. 20120921

res


Advanced Ingredient Data


Raw Label Data

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