VacuStim Black (Page 3 of 3)

Package Label — Lidocaine Hydrochloride Topical Solution USP 4%

NDC 0054-3505-47: Bottle of 50 mL

Rx Only

Roxane Laboratories, Inc.

0054-3505-47 Bottle Label.jpg
(click image for full-size original)

Carton Label — VacuStim Black Negative Pressure Wound Therapy / Lidocaine Dressing Kit Rx Only

Carton Label — VacuStim® Black
Negative Pressure Wound Therapy / Lidocaine Dressing Kit
​Rx Only

NDC 69263-911-01

Kit Contains:

3 Lidcocaine HCl Topical Solution, USP 4% (50 mL)

3 Luer-lock Syringes

3 Latex and Powder Free Sterile Gloves

3 Sterile 4″x4″ Gauze (10 pack)

1 Bandage Scissors

3 Debriding Mitts (4×4)

3 Chlorohexidine Gluconate 2%, Isopropyl Alcohol 70% Skin Scrub

3 Skin barier Wipes

3 VacuStim® Black NPWT Foam Dressing Packs

3 TRU-See Wound Calibration Slates

Distributed by:

OakLoack Bio

Canton, MS 39046

Carton Label
(click image for full-size original)
VACUSTIM BLACK
negative pressure wound therapy lidocaine dressing kit kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69263-911
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69263-911-01 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1
Part 1 of 1
LIDOCAINE HYDROCHLORIDE
lidocaine solution
Product Information
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE 40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
METHYLPARABEN
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088803 11/18/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088803 11/18/2015
Labeler — Oaklock, LLC (079559179)
Registrant — Oaklock, LLC (079559179)
Establishment
Name Address ID/FEI Operations
Boehringer Ingelheim Roxane Inc 058839929 manufacture (69263-911)
Establishment
Name Address ID/FEI Operations
Oaklock, LLC 079559179 pack (69263-911)
Establishment
Name Address ID/FEI Operations
Albemarle Corporation 788779192 api manufacture (69263-911)

Revised: 11/2017 Oaklock, LLC

Page 3 of 3 1 2 3

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.