NDC Code(s) : 49836-740-01
Packager : RX PHARMA-PACK, INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MLP A-1Bupivacaine Hydrochloride, Lidocaine Hydrochloride, Triamcinolone Acetonide, and Povidone-Iodine KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49836-740
Route of Administration DEA Schedule
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49836-740-011 in 1 PACKAGE, COMBINATION Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA014901 06/01/2009

PRINCIPAL DISPLAY PANEL

10 mL          Single-dose Vial          NDC 0409-1560-18

Preservative-Free                                        Rx only

Marcaine™ 0.5%
bupivacaine HCl injection, USP

50mg/10mL (5mg/mL)

For NERVE BLOCK,CAUDAL
and EPIDURAL ANESTHESIA
NOT FOR SPINAL ANESTHESIA

Hospira

Each mL contains 5 mg bupivacaine
HCI, with NaCl to make isotonic,
in Water for Injection. pH adjusted
with NaOH or HCl. Usual Dosage:
See insert. Store at 20 to 25ºC (68
to 77ºF). [See USP Controlled Room
Temperature.]

Discard unused portion.

Hospira, Inc.
Lake Forest, IL 60045 USA

Marcaine ImageMarcaine Image

PRINCIPAL DISPLAY PANEL

NDC 0409-4282-01

Rx only

2 mL Single-dose
Preservative-Free

2% LIDOCAINE HCl
Injection, USP
20 mg/mL

RL-0866 (11/04)
HOSPIRA, INC,
LAKE FOREST, IL
60045 USA 

Lidocaine 2 Percent

Lidocaine 2 Percent  

PRINCIPAL DISPLAY PANEL

NDC 0003-0293-05

KENALOG®-40
(Triamcinolone
Acetonide Injectable
Suspension, USP)

40 mg per 1 mL

Rx only 

Read all side

Bristol-Myers Squibb

Each mL provides 40 mg
triamcinolone acetonide with
0.65% sodium chloride for
isotonicity, 0.99% (w/v) benzyl
alcohol  added as a preservative,
0.75% carboxymethylcellulose
sodium, and 0.04% polysorbate
80 in an aqueous suspension;
sodium hydroxide or hydrochloric
acid may be present to adjust
pH to 5.0-7.5.

Shake well before using.

For Intramuscular or
intra-articular use only.

NOT FOR IV, ID, INTRAOCULAR,
EPIDURAL, OR INTRATHECAL
USE.

See insert for dosage
information.

Bristol-Myers Squibb Company
Princeton, NJ 08543 USA
Product of Spain     1132705A5

Store at controlled room
temperature, 20º -25ºC
(68º-77ºF), avoid freezing and
protect from light.

Do not refrigerate.

Store vial in carton.

See bottom panel for lot number
and expiration date.

Kenalog-40Kenalog-40

PRINCIPAL DISPLAY PANEL

NDC 52380-3101-5

NPN 02076101

APLICARE®

Tear Here               Hold Upright               Tear Here

THREE
POVIDONE-IODINE
SWABSTICKS

ANTISEPTIC
STERILE Solution
Applicator is STERILE if Package
is Intact

Three 4-inch Saturated Swabsticks

STERILE SOLUTION

Reorder No. S-3101

For questions, comments, or to report
serious side effects:
800-760-3236
Monday-Friday 8:30 a.m.-5:00 p.m. EST
APLICARE, INC.
MERIDEN, CT 06450 U.S.A.

DOLLARD-des-ORMEAUX,
QUEBEC H9G 2S3
www.aplicare.com
1114

Povidone IodinePovidone Iodine

PRINCIPAL DISPLAY PANEL

NDC 49836-740-01

RX-Only

MLP A-1

Kit Contains:

2 Kenalog-40® Single Dose Vial (1mL)
1 Marcaine® 0.5% Single Dose Vial (5mg/mL) (10mL)
1 Lidocaine HCl Injection, USP 2% Single Dose Ampule (20mg/mL) (2mL)
1 Sterile Povidone-Iodine Swabsticks (3 Swabs)
1 Pair Nitrile Powder Free Sterile Gloves (Size 7.5)
1 Sterile Towel Drape
1 Fenestrated Sterile Towel Drape
1 Sterile Adhesive Bandage
1 Pack of Sterile 4x4 Gauze (2 Gauzes)

1 Dose

Needles and Syringes Not Included

Distributed by:

DANEX INTERNATIONAL LLC
SPRING, TXl 77388

MANUFACTURED BY:

Rx
Pharma
Pack
HAUPPAUGE, NY 11788

Questions/Comments 1-844-632-7898

Kit Contents:

Kenalog-40® † (Bristol-Myers Squibb)*
Triamcinolone Acetonide Injectable Suspension, USP
Each mL Provides 40 mg triamcinolone acetonide with 0.65% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol added as a preservative, 0.75% carboxymethylcellulose sodium, and 0.04% polysorbate 80 in an aqueous suspension; sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0-7.5.

Marcaine® ‡ 0.5% (5mg/mL) (Hospira, Inc.)*
Each mL contains 5mg bupivacaine HCl, with NaCl to make isotonic, in Water for Injection. pH adjusted with NaOH or HCl.

Lidocaine HCl Injection, USP 2% (20mg/mL) (Hospira, Inc.)*
Each mL contains lidocaine hydrochloride, anhydrous 20mg; sodium chloride 6mg. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. pH 6.5 (5.0 to 7.0). 0.31 mOsmol/mL (calc).

Sterile Povidone-lodine Swabsticks (Aplicare)*

Nitrile Powder Free Sterile Gloves (Dynarex) Size 7.5*

Sterile Towel Drape (Dynarex)*

Fenestrated Sterile Towel Drape (Dynarex)*

Sterile Adhesive Bandage (Dynarex)*

Sterile 4x4 Gauze (Dynarex)*

† Kenalog® (registered trademark of Bristol-Myers Squibb)

‡ Marcaine® (registered trademark of Hospira, Inc.)

* Internal package components remain sterile as long as items are unopened and undamaged

WARNING: KEEP THIS AND ALL MEDICATION OUT
OF THE REACH OF CHILDREN. IN CASE OF
ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL
ASSISTANCE OR CONTACT A POISON CONTROL
CENTER IMMEDIATELY.

PROTECT FROM LIGHT I AVOID FREEZING

STORE AT CONTROLLED ROOM TEMPERATURE
20º-25ºC (68º-77º F) [SEE USP CONTROLLED
ROOM TEMPERATURE]

DO NOT REFRIGERATE.

Directions for Use: See enclosed inserts.

MLP A-1MLP A-1