PERINEZE TRIPLE DYE- brilliant green, proflavine hemisulfate, gentian violet solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BRILLIANT GREEN (UNII: G0L543D370) (BRILLIANT GREEN - UNII:G0L543D370), PROFLAVINE HEMISULFATE (UNII: 27V8M747VB) (PROFLAVINE HEMISULFATE - UNII:27V8M747VB), GENTIAN VIOLET (UNII: J4Z741D6O5) (GENTIAN VIOLET - UNII:J4Z741D6O5)

Available from:

Peace Medical Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Prevent Infection aids in the prevention of infection in the umbilical cord area of newborn none

Authorization status:

OTC monograph not final

Summary of Product characteristics

PERINEZE TRIPLE DYE - BRILLIANT GREEN, PROFLAVINE HEMISULFATE, GENTIAN
VIOLET SOLUTION
PEACE MEDICAL INC.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
----------
DRUG FACTS
ACTIVE INGREDIENTS (IN EACH DOSE)
Brilliant green 2.29 mg
Proflavine hemisulfate 1.14 mg
gentian violet 2.29 mg
PURPOS E
Prevent Infection
US E
aids in the prevention of infection in the umbilical cord area of
newborn
CONTRAINDICATIONS
none
WARNINGS
for external use only
KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
Peel paper portion of package down over base of ampule
Avoid touching tip during removal
With tip in downward position, pinch center to crush ampule.
Apply to area to be prepped using accepted technique.
Discard as non-hazardous waste.
OTHER INFORMATION
store at controlled room temperature 15-30 C (58-86 F)
INACTIVE INGREDIENTS
aqueous solution
PERINEZE TRIPLE DYE PACKAGE LABEL
Perineze® Triple Dye
o
o
UMBILICAL AREA ANTISEPTIC
Peace Medical, Inc.
CATALOG NUMBER 1022
250 UNIT DOSE AMPULES (.61 ML EACH)
NDC 55739-1022-3
Aids in prevention of infection in the umbilical area of the newborn.
PERINEZE TRIPLE DYE
brilliant green, proflavine hemisulfate, gentian violet solution
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:55739 -10 22
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
BRILLIANT GREEN (UNII: G0 L543D370 ) (BRILLIANT GREEN - UNII:G0
L543D370 )
BRILLIANT GREEN
2.29 mg
in 0 .6 1 mL
PRO FLAVINE HEMISULFATE (UNII: 27V8 M747VB) (PROFLAVINE HEMISULFATE -
UNII:27V8 M747VB)
PROFLAVINE
HEMISULFATE
1.14 mg
in 0 .6 1 mL
GENTIAN VIO LET (UNII: J4Z741D6 O5) (GENTIAN VIOLET - UNII:J4Z741D6
O5)
GENTIAN VIOLET
2.29 mg
in 0 .6 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:5573