Venipuncture Px1 (Page 3 of 3)

MAXIMUM DOSAGE

No more than 600 mg of lidocaine HCl should be given in any 12 hour period.

Children: It is difficult to recommend a maximum dosage 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, in a child of five years weighing 50 lbs., the dose of lidocaine hydrochloride should not exceed 75 to 100 mg when calculated according to Clark’s rule. In any case, the maximum amount of Lidocaine HCl administered should not exceed 4.5 mg/kg (2 mg/lb) of body weight.

HOW SUPPLIED

Lidocaine HCI 2% Jelly is supplied in the listed dosage forms.

NDC 17478-840-30 30 mL aluminum tube
NDC 17478-840-05 5 mL aluminum tube

A detachable applicator cone and a key for expressing the contents are included in the 30 mL carton.

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

PREMIERProRx®

Manufactured by:
Akorn, Inc.
Lake Forest, IL 60045

PremierProRx® is a registered trademark of Premier Inc., used under license.
PLD00N Rev. 10/15

Sterile Alcohol Prep Pads

Active Ingredient Purpose

Isopropyl Alcohol 70% v/v Antiseptic

Use: alcohol_prep

For preparation of the skin prior to injection.

Warnings:

  • For external use only
  • Flammable, keep away from flame or fire
  • Not for use with electrocautinary devices or procedures
  • Do not use in eyes
  • Sterile unless package is damaged or open.

Indications and Usage:

Stop use and ask a doctor if:

  • Irritation or redness develops
  • condition persists for more than 72 hours
  • Cleansing of an injection site

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Directions:

Wipe injection site vigorously and discard

Other information:

  • Store at room temperature: 15 deg C to 30 deg C 59 deg F to 86 deg F
  • avoid excessive heat

Inactive Ingredient

Inactive Ingredient

  • Water

Venipuncture Px1 Phlebotomy System (W/ 2 % Lidocaine Hydrochloride Jelly, USP- 5.0 mL)

Contents

1- Bio-Hazard Specimen Transport Bag

1-Pair of Sterile Vinyl Exam Gloves (Medium), Latex Free

2-Sheer Adhesive Bandages, Spots

1- Basic conforming Stretch Gauze, Non-sterile

1- Cohesive Wrap Bandage

2- Alcohol Prep Pads

1- Tourniquet, Latex free

1- Vacutainer Single Use Holder

1- Vacutainer Blood Collection Needle , Butterfly W/7″

Tubing, 23GX 3/4″

1- Vacutainer Eclipse Blood Collection Needle 21G X 1.25

3-Red Vacutainer SST Blood collection Tubes, 8.5 mL

1-Lavender Vacutainer EDTA Blood collection Tube 4.0 mL

1- 2% Lidocaine Hydrochloride Jelly, USP- 5.0 mL

Packaging-Kit Label

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Packaging- Kit Components Labeling

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VENIPUNCTURE PX1
lidocaine hydrochloride kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70529-254
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70529-254-01 1 KIT in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 TUBE 5 mL
Part 2 2 POUCH 1.1 mL
Part 1 of 2
LIDOCAINE
lidocaine hydrochloride jelly
Product Information
Item Code (Source) NDC:17478-840
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE, UNSPECIFIED
METHYLPARABEN
PROPYLPARABEN
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17478-840-05 1 TUBE in 1 CARTON contains a TUBE
1 5 mL in 1 TUBE This package is contained within the CARTON (17478-840-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040433 08/01/2013
Part 2 of 2
ALCOHOL PREP
isopropyl alcohol swab
Product Information
Item Code (Source) NDC:67777-121
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 0.7 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67777-121-13 0.55 mL in 1 POUCH None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 07/01/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040433 05/01/2016
Labeler — IT3 Medical LLC (079971231)

Revised: 02/2022 IT3 Medical LLC

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