MLK F3 Kit (Page 15 of 15)

Other information:

Store at room temperature.

Avoid excessive heat

For use as an

  • first aid antiseptic
  • pre-operative skin preperation

Inactive Ingredients

Inactive ingredients: Citric acid, glycerin, polysorbate 80, sodium citrate USP, sodium phosphate dibasic, water

PRINCIPAL DISPLAY PANEL

NDC: 76420-743-01

Rx Only

MLK F3 Kit™

Kit Contains

1 Bupivacaine HCI 0.5% Single Dose Vial (10mL)

2 Lidocaine HCI Injection, USP 2% (2mL)

2 Triamcinolone Acetonide Injectable Suspension, USP 40 mg/mL (1mL)

1 Povidone-Iodine Swabsticks (3 Swabs)

1 Pair Nitrile Powder Free Sterile Gloves (M)

1 Drape

1 Adhesive Bandage

5 Non Sterile 4×4 Gauze

Needles and Syringes Not Included

1 Dose

Single Use Only

Distributed by
Enovachem™
PHARMACEUTICALS Torrance, CA 90501

image description
(click image for full-size original)
MLK F3 KIT marcaine, lidocaine, kenalog, povidone iodine kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76420-743
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76420-743-01 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 2 VIAL 2 mL
Part 2 1 PACKET 0.9 mL
Part 3 1 VIAL, SINGLE-DOSE 10 mL
Part 4 2 VIAL, SINGLE-DOSE 4 mL
Part 1 of 4
TRIAMCINOLONE ACETONIDE triamcinolone acetonide injection, suspension
Product Information
Item Code (Source) NDC:70121-1049
Route of Administration INTRAMUSCULAR, INTRA-ARTICULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE 40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
BENZYL ALCOHOL
CARBOXYMETHYLCELLULOSE SODIUM
POLYSORBATE 80
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Product Characteristics
Color white (white to cream-color) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70121-1049-5 25 VIAL in 1 CARTON contains a VIAL
1 1 mL in 1 VIAL This package is contained within the CARTON (70121-1049-5)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207550 12/11/2017
Part 2 of 4
POVIDINE IODINE povidine iodine swab
Product Information
Item Code (Source) NDC:67777-419
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POVIDONE-IODINE (IODINE) IODINE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
POLYSORBATE 80
SODIUM CITRATE
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
CITRIC ACID ACETATE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67777-419-02 0.9 mL in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 09/13/2016
Part 3 of 4
BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride injection, solution
Product Information
Item Code (Source) NDC:0409-1162
Route of Administration EPIDURAL, INTRACAUDAL, PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE) BUPIVACAINE HYDROCHLORIDE ANHYDROUS 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 8.1 mg in 1 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-1162-18 10 mL in 1 VIAL, SINGLE-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070584 11/22/2005
Part 4 of 4
LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride injection, solution
Product Information
Item Code (Source) NDC:55150-164
Route of Administration EPIDURAL, INFILTRATION 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
SODIUM CHLORIDE 6 mg in 1 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55150-164-02 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 2 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (55150-164-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203082 03/14/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/04/2014
Labeler — Asclemed USA, Inc. (059888437)

Revised: 07/2023 Asclemed USA, Inc.

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