FDA Label for Tineacide Antifungal

View Indications, Usage & Precautions

Tineacide Antifungal Product Label

The following document was submitted to the FDA by the labeler of this product Blaine Labs Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Drug Facts

Active Ingredient

Miconazole Nitrate 2%


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.


Uses



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

Warnings



  • For external use only.
  • Do not use in or near the mouth or eyes.
  • Do not use for vaginal yeast infections.

When Using This Product,



do not get into the eyes. If eye contact occurs, rinse thoroughly with water.


Stop Use And Consult 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



  • Adult and children 2 years and older. Children under 2 years: ask physician.
  • Wash the affected area with soap and water and dry thoroughly before applying.
  • For athlete's foot between the toes: apply to affected skin between and around the toes twice a day for 4 weeks (morning and night), or as directed by a physician.Wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
  • For jock itch and ringworm apply twice daily to affected skin for 2 weeks or as directed by a physician. This product is not effective on the scalp or mails.
  • Wash hands after each use.

Other Information



  • Do not use if seal on bottle is broken or is not visible.
  • Store between 2°  and 30°  C (36°  and 85°  F)

Inactive Ingredients



Aloe Barbadensis Leaf Juice, Cetyl Alcohol, Clotrimazole, Coco-Caprylate/Caprate, Disodium EDTA, Glyceryl Stearate, Hydroxyethylcellulose, lavandula Angustifolia Lavender Oil, Methylparaben, PEG-100 Stearate, Polysorbate 60, Propylparaben, Stearic Acid, Tea Tree Oil, Triethanolamine, Urea, Water.


Product Label



Dr. Blaine's

TINEACIDE®

Antifungal Cream

Kills the skin fungus that causes fungal nails

Treats mild to severe infections

NET WT 1.25 OZ (35 g)

5 FUNGUS FIGHTERS

NEW and IMPROVED FORMULATION  100% MONEY-BACK GUARANTEE!

BONUS: Easy-Grip, Heavy-Duty Nail Clipper!

EXP.

Proudly made in the U.S.A.!

Please Recycle! This package is made from recyclable materials.

Questions or Comments? Call (800) 307-8818 Monday-Friday 8:00AM and 5:00PM (EST)

Blaine Labs Inc. Santa Fe Springs, CA 90670  www.DrBlaines.com  All rights reserved.

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