NDC Code(s) : 0002-1975-90, 0002-1975-61, 0002-1977-90
Packager : Eli Lilly and Company

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AXIRON testosterone SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0002-1975
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:0002-1975-901 in 1 CARTON 28/03/2011
190 mL in 1 BOTTLE, WITH APPLICATOR Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0002-1975-611 in 1 CARTON 28/03/2011
290 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 NDA022504 11/23/2010
AXIRON testosterone SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0002-1977
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:0002-1977-901 in 1 CARTON 13/07/2017
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 NDA022504 11/23/2010

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL – Axiron Bottle 30mg

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

NDC 0002-1975-90

TS 1975

Axiron®

(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

www.axiron.com

Lilly

PACKAGE LABEL – Axiron Bottle 30mg 1ct

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL – Axiron Twist Bottle 30mg 1ct

NDC 0002-1977-90

TS 1977

Rx Only

Axiron®

(testosterone) topical solution

30 mg of testosterone per twist*

CIII

*Each twist delivers 1.5 mL of solution.

For topical use only.

Dispense the enclosed Medication Guide and Prescribing Information to each patient.

www.axiron.com

Lilly

Please read the full Instructions for Use (found inside the box).

Lift here to see brief instructions for using AXIRON.

PACKAGE LABEL – Axiron Twist Bottle 30mg 1ct