VITE20- miconazole nitrate liquid

Vite20 by

Drug Labeling and Warnings

Vite20 by is a Otc medication manufactured, distributed, or labeled by Blaine Labs Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTSActive 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.

INDICATIONS

• Cures most Athlete's Foot (Tinea Pedis), Jock Itch (Tinea Cruris), and Ringworm (Tinea Corporis)
• Relieves Itching, cracking, burning and scaling.  which accompany these conditions
• Prevents most Athlete's Foot with daily use

WARNINGS

• For external use only
• Do not use :
•    On children under two (2) years of age unless directed by a physician
• In or near the mouth or the eyes
• For vaginal yeast infections

When using this product

avoid contact with the eyes. If contact occurs, rinse thoroughly with water.

Stop use and consult a physician

if irritation occurs or if there is no improvement within four (4) weeks (for Athlete's Foot or Ringworm) or within two (2) weeks (for Jock Itch)

DIRECTIONS

• Was the affected area with soap and water, dry thorougly, then apply sparingly over the affected area. Use twice daily (morning and night) or as directed by a physician
• Supervise children in the use of this product
• For Athlete's Foot and Ringworm, use daily for four (4) weeks. For Jock Itch, use daily for two (2) weeks. If condition persists longer, consult a physician
• Wash hands after each use.

Other Information

• Store at room temperature

INACTIVE INGREDIENTS

Isopropyl Alcohol, Deionized Water, Triethanokamine, Glycerin, Hydroxypropylcelluose, Tocopheryl Acetate, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Isobutylparaben, Phenoxyethanol

Vite20 product label

VITÉ 20

BRUSH - ON

NDC# 63347-810-01

Vité20®

BRUSH-ON

KILLS FUNGUS

Maxium Strength

Professional Formula

15 mL (0.5 FL OZ)

SEE SIDE PANEL FOR MORE INFORMATION

KILLS FUNGUS

*Made in the U.S.A.

Questions or Comments?

Call 800-307-8818 M-F

7:00 am - 5:00 pm PST

www.vite20.com

Manufactured by:

Blaine Labs, Inc.

11037 Lockport Place

Santa Fe Springs, CA 90670

Please recycle!

This package is made from recyclable materials

06100-p-bx01

res

INGREDIENTS AND APPEARANCE

VITE20 
miconazole nitrate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63347-810
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	0.30 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63347-810-01	1 in 1 BOX	04/01/2016
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	04/01/2016

Labeler - Blaine Labs Inc. (017314571)

Registrant - Blaine Labs Inc. (017314571)

Establishment
Name	Address	ID/FEI	Business Operations
Blaine Labs Inc.		017314571	manufacture(63347-810)