Testone CIK (Page 3 of 3)

HOW SUPPLIED

Testosterone Cypionate Injection, USP, 200 mg/mL is available as follows:

1 mL vials NDC 0574-0820-01

Vials should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Use carton to protect contents from light until used.

This product’s label may have been updated. For current full prescribing information, please visit www.perrigo.com.

Manufactured By
PharmaForce, Inc.
Hilliard, OH 43026

Manufactured For
Perrigo^®
Minneapolis, MN 55427

9Z800 RC J8

Rev 12-16 G

Isopropyl Alcohol 70% Prep Pad

Active Ingredient Purpose

Isopropyl Alcohol 70% v/v Antiseptic

Use:

For preparation of the skin prior to injection.

Warnings:

• For external use only
• Flammable, keep away from flame or fire
• Not for use with electrocautinary devices or procedures
• Do not use in eyes

Stop use and ask a doctor if:

• Irritation or redness develops
• condition persists for more than 72 hours
• Cleansing of an injection site

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Directions:

Wipe injection site vigorously and discard

Other information:

• Store at room temperature: 15 deg C to 30 deg C 59 deg F to 86 deg F
• avoid excessive heat

Inactive Ingredient

Inactive Ingredient

• Water

Principal Display Panel

NDC: 76420-650-01

RX-Only

Testone CIK™ CIII

Kit Contains

1 Testosterone Cypionate Injection, USP 200mg/mL (1mL)

1 Isopropyl Alcohol 70% Prep Pad

1 Pair Nitrile Powder Free Sterile Gloves (M)

1 Drape

1 Adhesive Bandage

5 Non Sterile 4×4 Gauze

Needles and Syringes Not Included

1 Dose

Single Use Only

Distributed by:

Enovachem™

PHARMACEUTICALS

Torrance, CA 90501

TESTONE CIK testosterone cypionate, alcohol kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76420-650

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:76420-650-01 1 KIT in 1 CARTON None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 VIAL, GLASS 1 mL Part 2 1 POUCH 1.4 mL

Part 1 of 2 TESTOSTERONE CYPIONATE testosterone cypionate injection, solution

Product Information Item Code (Source) NDC:0574-0820 Route of Administration INTRAMUSCULAR DEA Schedule CIII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TESTOSTERONE CYPIONATE (TESTOSTERONE) TESTOSTERONE CYPIONATE 200 mg in 1 mL

Inactive Ingredients Ingredient Name Strength BENZYL BENZOATE BENZYL ALCOHOL COTTONSEED OIL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0574-0820-01 1 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS 1 1 mL in 1 VIAL, GLASS This package is contained within the CARTON (0574-0820-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040530 12/21/2007

Part 2 of 2 ALCOHOL alcohol swab

Product Information Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 0.7 mL in 1 mL

Inactive Ingredients Ingredient Name Strength WATER

Packaging # Item Code Package Description Multilevel Packaging 1 1.4 mL in 1 POUCH None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part344 03/01/2010

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/21/2007

Labeler — Asclemed USA, Inc. (059888437)

Revised: 09/2020 Asclemed USA, Inc.