TINEACIDE Antifungal: Package Insert and Label Information

TINEACIDE ANTIFUNGAL- miconazole nitrate cream
Blaine Labs Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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!

Blaine TINEACIDE5021 Label
(click image for full-size original)

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.

Blaine TINEACIDE502 Label
(click image for full-size original)

res

TINEACIDE ANTIFUNGAL
miconazole nitrate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63347-502
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE 0.7 g in 35 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
CETYL ALCOHOL
CLOTRIMAZOLE
COCO-CAPRYLATE/CAPRATE
EDETATE DISODIUM
GLYCERYL MONOSTEARATE
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)
LAVENDER OIL
METHYLPARABEN
PEG-100 STEARATE
POLYSORBATE 60
PROPYLPARABEN
STEARIC ACID
TEA TREE OIL
TROLAMINE
UREA
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63347-502-01 35 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 06/01/2013
Labeler — Blaine Labs Inc. (017314571)
Registrant — Blaine Labs Inc. (017314571)
Establishment
Name Address ID/FEI Operations
Blaine Labs Inc. 017314571 manufacture (63347-502)

Revised: 01/2020 Blaine Labs Inc.

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