Prescription Drug Information: LIDOCAINE HCI AND DEXTROSE (Page 2 of 2)

HOW SUPPLIED

Lidocaine Hydrochloride and 5% Dextrose Injection USP is supplied sterile and nonpyrogenic in Full Fill 500 mL and 250 mL EXCEL® Containers packaged 24 per case.

HS
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Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.

SPL UNCLASSIFIED

Rx only

Revised: November 2019

EXCEL is a registered trademark of B. Braun Medical Inc.

DIRECTIONS FOR USE OF EXCEL® CONTAINER

Do not admix with other drugs.

Caution: Do not use plastic containers in series connection.

To Open

Tear overwrap down at notch and remove solution container. Check for minute leaks by squeezing solution container firmly. If leaks are found, discard solution as sterility may be impaired.

NOTE: Before use, perform the following checks:

Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date.

Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter.
Any container which is suspect should not be used.

Use only if solution is clear and container and seals are intact.

Preparation for Administration

Remove plastic protector from sterile set port at bottom of container.
Attach administration set. Refer to complete directions accompanying set.

SPL UNCLASSIFIED

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862

Y36-003-016 LD-236-8

PRINCIPAL DISPLAY PANEL — 51662-1565-1 250 mL CONTAINER (BAG) — LABEL AND SERIALIZED LABELING

51662-1565-1

LIDOCAINE HCI AND 5% DEXTROSE INJECTION USP, 2g (8mg/mL) 250mL BAG

BAG
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SERIALIZED
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LIDOCAINE HCI AND DEXTROSE
lidocaine hci and dextrose injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51662-1565(NDC:0264-9598)
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 5 g in 100 mL
LIDOCAINE HYDROCHLORIDE ANHYDROUS (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 0.8 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51662-1565-1 250 mL in 1 CONTAINER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019830 07/17/2021
Labeler — HF Acquisition Co LLC, DBA HealthFirst (045657305)
Registrant — HF Acquisition Co LLC, DBA HealthFirst (045657305)
Establishment
Name Address ID/FEI Operations
HF Acquisition Co LLC, DBA HealthFirst 045657305 relabel (51662-1565)

Revised: 07/2021 HF Acquisition Co LLC, DBA HealthFirst

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