Tineacide Liquid
FDA Label NDC 63347-511

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Blaine Labs Inc. for the product Tineacide (NDC 63347-511). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, keep out of reach of children, indications, warnings, when using this product, stop use and consult a physician, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Drug facts

Active Ingredient

TOLNAFTATE 1%

Purpose

Purpose

Antifungal

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.

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.

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

When Using This Product

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

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).

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.

Other Information

Other Information

  • Store at room temperature.

Questions?

Questions?

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

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.

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

Blaine Tineacide Sol1 (Blaine Tineacide Sol)

Blaine Tineacide Sol1 (Blaine Tineacide Sol)

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