TINEACIDE ANTIFUNGAL- miconazole nitrate cream

TINEACIDE by

Drug Labeling and Warnings

TINEACIDE by is a Otc medication manufactured, distributed, or labeled by Blaine Labs Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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INGREDIENTS AND APPEARANCE

TINEACIDE  ANTIFUNGAL
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63347-502
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	0.7 g  in 35 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETYL ALCOHOL (UNII: 936JST6JCN)
CLOTRIMAZOLE (UNII: G07GZ97H65)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)
LAVENDER OIL (UNII: ZBP1YXW0H8)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARIC ACID (UNII: 4ELV7Z65AP)
TEA TREE OIL (UNII: VIF565UC2G)
TROLAMINE (UNII: 9O3K93S3TK)
UREA (UNII: 8W8T17847W)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63347-502-01	35 g in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2013

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	Business Operations
Blaine Labs Inc.		017314571	manufacture(63347-502)