Lidocaine (Page 3 of 3)

Dosage for children

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children less than ten years who have a normal lean body mass and a normal lean body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (e.g., Clark’s rule). For example a child of five years weighing 50 lbs., the dose of lidocaine should not exceed 75 to 100 mg when calculated according to Clark’s rule. In any case, the maximum amount of lidocaine administered should not exceed 4.5 mg/kg (2 mg/lb) of body weight.

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 35.44 g (1¼ oz) laminate tubes with a child-resistant cap (NDC 68462-418-20) and 50 g jar (NDC 68462-418-27).

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Manufactured by:

Glenmark Pharmaceuticals Ltd.
Colvale-Bardez, Goa 403 513, India

Manufactured for:

Glenmark Logo

Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430

Questions? 1 (888)721-7115
www.glenmarkpharma.com/usa

October 2018

Package/Label Display Panel

pdp
(click image for full-size original)

LIDOCAINE
lidocaine ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45865-990(NDC:68462-418)
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 1450
POLYETHYLENE GLYCOL 300
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45865-990-01 50 g in 1 JAR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206498 07/01/2016
Labeler — medsource pharmaceuticals (833685915)
Establishment
Name Address ID/FEI Operations
medsource pharmaceuticals 833685915 relabel (45865-990)

Revised: 12/2019 medsource pharmaceuticals

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