Lidocaine (Page 3 of 3)

Administration

For medical use, apply topically for adequate control of symptoms. The use of a sterile gauze pad is suggested for application to broken skin tissue. Apply to the tube prior to intubation.

In dentistry, apply to previously dried oral mucosa. Subsequent removal of excess saliva with cotton rolls or saliva ejector minimizes dilution of the ointment, permits maximum penetration, and minimizes the possibility of swallowing the topical ointment.

For use in connection with the insertion of new dentures, apply to all denture surfaces contacting mucosa.

IMPORTANT: Patients should consult a dentist at intervals not exceeding 48 hours throughout the fitting period.

HOW SUPPLIED

Lidocaine Ointment USP, 5% is available in a 50 g Jar with a child-resistant cap (NDC 51672-3008-5).

NOTE — JARS ARE FILLED BY WEIGHT NOT VOLUME.

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

Pharmacist: Dispense in tight containers as specified in USP. If dispensed to a consumer, provide child-resistant package for dispensing.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Keep Tightly Closed.

Rx only

Mfd. by: Taro Pharmaceuticals Inc.
Brampton, Ontario, Canada L6T 1C1
Dist. by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532
Revised: March, 2019

PPK-8752-3 0319-3 75

PRINCIPAL DISPLAY PANEL — 50 g Jar Carton

NDC 51672-3008-5

50 g

Lidocaine
Ointment
USP, 5% (Spearmint Flavored)

FOR TOPICAL USE ONLY.
DO NOT USE IN THE EYES

Rx only

TARO

Keep this and all medications out of the reach of children.

PRINCIPAL DISPLAY PANEL -- 50 g Jar Carton
(click image for full-size original)
LIDOCAINE
lidocaine ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51672-3008
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Lidocaine (Lidocaine) Lidocaine 50 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
polyethylene glycol 400
polyethylene glycol 3350
propylene glycol
Product Characteristics
Color WHITE (off-white) Score
Shape Size
Flavor SPEARMINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51672-3008-5 1 JAR in 1 CARTON contains a JAR
1 50 g in 1 JAR This package is contained within the CARTON (51672-3008-5)
2 NDC:51672-3008-3 50 g in 1 JAR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086724 08/17/1981
Labeler — Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
Name Address ID/FEI Operations
Taro Pharmaceuticals Inc. 206263295 MANUFACTURE (51672-3008)

Revised: 06/2019 Taro Pharmaceuticals U.S.A., Inc.

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