FDA Label for Perineze Triple Dye
View Indications, Usage & Precautions
Perineze Triple Dye Product Label
The following document was submitted to the FDA by the labeler of this product Peace Medical Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients (In Each Dose)
Brilliant green 2.29 mg
Proflavine hemisulfate 1.14 mg
gentian violet 2.29 mg
Purpose
Prevent Infection
Use
aids in the prevention of infection in the umbilical cord area of newborn
Contraindications
none
Warnings
for external use only
Otc - Keep Out Of Reach Of Children
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 15-30oC (58-86oF)
Inactive Ingredients
aqueous solution
Perineze Triple Dye Package Label
Perineze® Triple Dye
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.
* Please review the disclaimer below.