Vite20 - 810

Vite20 - 810
SPL v5
SPL
SPL Set ID 28a8d0dd-aab9-44ff-bab6-7ec4b5036a71
Route
TOPICAL
Published
Effective Date 2019-05-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (0.30 mg)
Inactive Ingredients
Isopropyl Alcohol Water Trolamine Glycerin Hydroxypropyl Cellulose, Unspecified .alpha.-tocopherol Acetate Methylparaben Ethylparaben Propylparaben Butylparaben Isobutylparaben Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-04-01

Description

Miconazole Nitrate 2%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Miconazole Nitrate 2%

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
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.
Drug Facts

Miconazole Nitrate 2%

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
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

When Using This Product

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

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.

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)


Structured Label Content

Purpose

Antifungal

Warnings (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
Directions (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.
Drug Facts (DRUG FACTS)

Miconazole Nitrate 2%

Indications (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
Other Information
  • Store at room temperature
Inactive Ingredients (INACTIVE INGREDIENTS)

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

Vite20 Product Label (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

When Using This Product (When using this product)

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

Keep Out of Reach of Children. (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.

Stop Use and Consult A Physician (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)


Advanced Ingredient Data


Raw Label Data

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