55739-1022 NDC - PERINEZE TRIPLE DYE (BRILLIANT GREEN, PROFLAVINE HEMISULFATE, GENTIAN VIOLET)

Drug Information

Product NDC: 55739-1022

Proprietary Name: Perineze Triple Dye

Non Proprietary Name: BRILLIANT GREEN, PROFLAVINE HEMISULFATE, GENTIAN VIOLET

Active Ingredient(s):
  • 2.29 mg/.61mL BRILLIANT GREEN;
  • 2.29 mg/.61mL GENTIAN VIOLET;
  • 1.14 mg/.61mL PROFLAVINE HEMISULFATE


Administration Route(s): TOPICAL

Dosage Form(s): SOLUTION

Labeler Information

Labeler Name: Peace Medical Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number: part333E
Marketing Category: OTC MONOGRAPH NOT FINAL
Start Marketing Date:9/28/2011

Package Information

No. Package Code Package Description
1 55739-1022-3 250 AMPULE in 1 BOX (55739-1022-3) > .61 mL in 1 AMPULE

NDC Record

No. Field Name Field Value
1 PRODUCT NDC 55739-1022
2 PRODUCT TYPE NAME HUMAN OTC DRUG
3 PROPRIETARY NAME Perineze Triple Dye
4 NON PROPRIETARY NAME BRILLIANT GREEN, PROFLAVINE HEMISULFATE, GENTIAN VIOLET
5 DOSAGE FORM NAME SOLUTION
6 ROUTE NAME TOPICAL
7 START MARKETING DATE 9/28/2011
8 MARKETING CATEGORY NAME OTC MONOGRAPH NOT FINAL
9 APPLICATION NUMBER part333E
10 LABELER NAME Peace Medical Inc.
11 SUBSTANCE NAME BRILLIANT GREEN; GENTIAN VIOLET; PROFLAVINE HEMISULFATE
12 ACTIVE NUMERATOR STRENGTH 2.29; 2.29; 1.14
13 ACTIVE INGRED UNIT mg/.61mL; mg/.61mL; mg/.61mL

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This page was last updated on: 10/17/2014