Lidocaine and Prilocaine: Package Insert and Label Information (Page 3 of 3)

Adult Patients-Intact Skin

A thick layer of lidocaine and prilocaine cream is applied to intact skin and covered with an occlusive dressing (see INSTRUCTIONS FOR APPLICATION).

Minor Dermal Procedures: For minor procedures such as intravenous cannulation and venipuncture, apply 2.5 grams of lidocaine and prilocaine cream (1/2 the 5 g tube) over 20 to 25 cm2 of skin surface for at least 1 hour. In controlled clinical trials using lidocaine and prilocaine cream, two sites were usually prepared in case there was a technical problem with cannulation or venipuncture at the first site.

Major Dermal Procedures: For more painful dermatological procedures involving a larger skin area such as split thickness skin graft harvesting, apply 2 grams of lidocaine and prilocaine cream per 10 cm2 of skin and allow to remain in contact with the skin for at least 2 hours.

Adult Male Genital Skin: As an adjunct prior to local anesthetic infiltration, apply a thick layer of lidocaine and prilocaine cream (1 g/10 cm2) to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of lidocaine and prilocaine cream.

Dermal analgesia can be expected to increase for up to 3 hours under occlusive dressing and persist for 1 to 2 hours after removal of the cream. The amount of lidocaine and prilocaine absorbed during the period of application can be estimated from the information in Table 2, ** footnote, in Individualization of Dose.

Adult Female Patients-Genital Mucous Membranes

For minor procedures on the female external genitalia, such as removal of condylomata acuminata, as well as for use as pretreatment for anesthetic infiltration, apply a thick layer (5 to 10 grams) of lidocaine and prilocaine cream for 5 to 10 minutes.

Occlusion is not necessary for absorption, but may be helpful to keep the cream in place. Patients should be lying down during the lidocaine and prilocaine cream application, especially if no occlusion is used. The procedure or the local anesthetic infiltration should be performed immediately after the removal of lidocaine and prilocaine cream.

Pediatric Patients-Intact Skin

The following are the maximum recommended doses, application areas and application times for lidocaine and prilocaine cream based on a child’s age and weight:

Age and Body WeightRequirements

Maximum TotalDose of Lidocaine andPrilocaine Cream

MaximumApplication Area

MaximumApplication Time

0 up to 3 months or < 5 kg

1 g

10 cm2

1 hour

3 up to 12 months and > 5 kg

2 g

20 cm2

4 hours

1 to 6 years and > 10 kg

10 g

100 cm2

4 hours

7 to 12 years and > 20 kg

20 g

200 cm2

4 hours

Please note: If a patient greater than 3 months old does not meet the minimum weight requirement, the maximum total dose of lidocaine and prilocaine cream should be restricted to that which corresponds to the patient’s weight (see INSTRUCTIONS FOR APPLICATION).

Practitioners should carefully instruct caregivers to avoid application of excessive amounts of lidocaine and prilocaine cream (see PRECAUTIONS).

When applying lidocaine and prilocaine cream to the skin of young children, care must be taken to maintain careful observation of the child to prevent accidental ingestion of lidocaine and prilocaine cream or the occlusive dressing. A secondary protective covering to prevent inadvertent disruption of the application site may be useful.

Lidocaine and prilocaine cream should not be used in neonates with a gestational age less than 37 weeks nor in infants under the age of 12 months who are receiving treatment with methemoglobin-inducing agents (see Methemoglobinemia subsection of WARNINGS).

When lidocaine and prilocaine cream (lidocaine 2.5% and prilocaine 2.5%) is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered (see Individualization of Dose). The amount absorbed in the case of lidocaine and prilocaine cream is determined by the area over which it is applied and the duration of application under occlusion (see Table 2, ** footnote, in Individualization of Dose).

Although the incidence of systemic adverse reactions with lidocaine and prilocaine cream is very low, caution should be exercised, particularly when applying it over large areas and leaving it on for longer than 2 hours. The incidence of systemic adverse reactions can be expected to be directly proportional to the area and time of exposure (see Individualization of Dose).

INSTRUCTIONS FOR APPLICATION:

To measure 1 gram of lidocaine and prilocaine cream, the Cream should be gently squeezed out of the tube as a narrow strip that is 1.5 inches (3.8 cm) long and 0.2 inches (5 mm) wide. The strip of lidocaine and prilocaine cream should be contained within the lines of the diagram shown below.

Figure

Use the number of strips that equals your dose, like the examples in the table below.

Dosing Information

1 gram = 1 strip
2 grams = 2 strips2.5 grams = 2.5 strips

For adult and pediatric patients, apply ONLY as prescribed by your physician.

If your child is below the age of 3 months or small for their age, please inform your doctor before applying lidocaine and prilocaine cream, which can be harmful, if applied over too much skin at one time in young children.

When applying lidocaine and prilocaine cream to the intact skin of young children, it is important that they be carefully observed by an adult in order to prevent the accidental ingestion of or eye contact with lidocaine and prilocaine cream.

Lidocaine and prilocaine cream must be applied to intact skin at least 1 hour before the start of a routine procedure and for 2 hours before the start of a painful procedure. A protective covering of the cream is not necessary for absorption but may be helpful to keep the cream in place.

If using a protective covering, your doctor will remove it, wipe off the lidocaine and prilocaine cream, and clean the entire area with an antiseptic solution before the procedure. The duration of effective skin anesthesia will be at least 1 hour after removal of the protective covering.

Precautions

Do not apply near eyes or open wounds.
Keep out of the reach of children.
If your child becomes very dizzy, excessively sleepy, or develops duskiness of the face or lips after applying lidocaine and prilocaine cream, remove the cream and contact the child’s physician at once.

HOW SUPPLIED

Lidocaine 2.5% and Prilocaine 2.5% Cream, USP is available as the following:

NDC No.

Strength

Size

63187-577-30

30 gram/tube

packed individually, in a child-resistant tube.

NOT FOR OPHTHALMIC USE.

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

Storage: Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].

Rx only

Keep out of the reach of children.

For all medical inquiries contact:
ACTAVIS
Medical Communications
Parsippany, NJ 07054
1-800-272-5525

Manufactured By:
IGI Laboratories Inc.
Buena, NJ 08310 USA

Distributed By:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Relabeled by:

Proficient Rx, LP

Thousand Oaks, CA 91320

Content Updated: June 2014
76626

PRINCIPAL DISPLAY PANEL

Lidocaine 2.5% and Prilocaine 2.5%
NDC 63187-577-30Carton x 1 30 gram

63187-577-30
(click image for full-size original)
LIDOCAINE AND PRILOCAINE lidocaine and prilocaine cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63187-577(NDC:0591-2070)
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
PEG-54 HYDROGENATED CASTOR OIL
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)
WATER
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63187-577-30 1 TUBE in 1 CARTON contains a TUBE
1 30 g in 1 TUBE This package is contained within the CARTON (63187-577-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA019941 11/12/2012
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 REPACK (63187-577), RELABEL (63187-577)

Revised: 01/2021 Proficient Rx LP

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