Your browser does not support JavaScript! TINEACIDE ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [BLAINE LABS INC.]
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TINEACIDE ANTIFUNGAL (miconazole nitrate) cream
[Blaine Labs Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

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!

Blaine TINEACIDE5021 Label

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

TINEACIDE  ANTIFUNGAL
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63347-502
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE0.7 g  in 35 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63347-502-0135 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C06/01/2013
Labeler - Blaine Labs Inc. (017314571)
Registrant - Blaine Labs Inc. (017314571)
Establishment
NameAddressID/FEIBusiness Operations
Blaine Labs Inc.017314571manufacture(63347-502)

Revised: 5/2013
 
Blaine Labs Inc.

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