NDC Code(s) : 66993-963-89
Packager : Prasco Laboratories

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TESTOSTERONE testosterone SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66993-963
Route of Administration TOPICAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TESTOSTERONE(UNII: 3XMK78S47O)
(TESTOSTERONE - UNII:3XMK78S47O) 		TESTOSTERONE30 mg in 1.5 mL
Inactive Ingredients
Ingredient Name Strength
OCTISALATE(UNII: 4X49Y0596W)
POVIDONE(UNII: FZ989GH94E)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
ALCOHOL(UNII: 3K9958V90M)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66993-963-891 in 1 CARTON 28/06/2017
190 mL in 1 BOTTLE, WITH APPLICATOR Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA022504 01/23/2017 12/31/2018

PRINCIPAL DISPLAY PANEL

If the seal is broken before first use, contact your pharmacist

NDC 66993-963-89

Prasco

Testosterone Topical Solution

30 mg of testosterone per pump actuation*

CIII

*Each actuation delivers 1.5 mL of solution

Multi-dose pump capable of dispensing 60 metered pump actuations.

For topical use only with enclosed applicator

Dispense the enclosed Medication Guide to each patient

Rx Only

PACKAGE LABEL – Testosterone Topical Solution Bottle 30mg 1ct