LIDO BDK (Page 6 of 6)

HOW SUPPLIED

Lidocaine and prilocaine cream USP, 2.5%/2.5% is available as the following:

NDC 0115-1468-60: 5 gram tube (NDC 0115-1468-53), box of 5

NDC 0115-1468-45: 30 gram tube, box of 1

Xylocaine and Citanest are registered trademarks of ABRAXIS BIOSCIENCE and DENTSPLY PHARM, respectively, and are not the trademarks of TOLMAR Inc.

NOT FOR OPHTHALMIC USE. KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.

Store at 20° — 25°C (68° — 77°F) [see USP Controlled Room Temperature].

44942 Rev. 1 09/15

Manufactured by:
TOLMAR Inc.
Fort Collins, CO 80526
Distributed by:
Impax Generics
Hayward, CA 94544

Principal Display Panel — Package Label

NDC 0115-1468-53 Rx only

Lidocaine and Prilocaine Cream, USP

2.5% / 2.5%

5 grams Impax

FOR TOPICAL USE ONLY

Principal Display Panel -- Package Label
(click image for full-size original)

Principal Display Panel – Carton Label

NDC: 76420-641-01 Rx Only

LIDO BDK

Kit Contains

1 Lidocaine and Prilocaine Cream, USP 2.5%/2.5% (5 grams)

2 SST™ Collection Tube (8.5mL)

1 K2 EDTA Collection Tube (4mL)

1 Vacutainer (Single Use)

1 Hypodermic Needle (21G x 1”)

1 Tourniquet 1” x 18” (Non-Latex)

1 Pair Nitrile Powder Free Sterile Gloves (M)

1 Adhesive Bandage

1 Cotton Ball

3 Non-Sterile 4×4 gauze

1 Isopropyl Alcohol 70% Prep Pad

1 Biohazard Specimen Collection Bag 6”x9

1 Dose

Single Use Only

Distributed by

Enovachem

PHARMACEUTICALS

Torrance, CA 90501

Principal Display Panel – Carton Label
(click image for full-size original)
LIDO BDK
lidocaine, prilocaine cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76420-641
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE (LIDOCAINE) LIDOCAINE 25 mg in 1 g
PRILOCAINE (PRILOCAINE) PRILOCAINE 25 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
POLYOXYL 60 HYDROGENATED CASTOR OIL
SODIUM HYDROXIDE
CARBOMER 934
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76420-641-01 1 TUBE in 1 CARTON contains a TUBE
1 5 g in 1 TUBE This package is contained within the CARTON (76420-641-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/27/2003
Labeler — Asclemed USA, Inc. (059888437)

Revised: 11/2018 Asclemed USA, Inc.

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