NDC | 63347-810-01 |
Set ID | 28a8d0dd-aab9-44ff-bab6-7ec4b5036a71 |
Category | HUMAN OTC DRUG LABEL |
Packager | Blaine Labs Inc. |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- DRUG FACTSActive Ingredient
- Purpose
- Keep out of reach of children.
- INDICATIONS
- WARNINGS
- When using this product
- Stop use and consult a physician
-
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
- INACTIVE INGREDIENTS
-
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
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 liquidProduct 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)