Marbeta 25 Kit (Page 7 of 7)

HOW SUPPLIED

These solutions are not for spinal anesthesia.
Bupivacaine hydrochloride injection, USP — Solution of bupivacaine hydrochloride injection, USP may be autoclaved. Autoclave at 15-pound pressure, 121°C (250°F) for 15 minutes.
Bupivacaine hydrochloride injection, USP is a clear, colorless, sterile isotonic solution and is available as follows:
Bupivacaine hydrochloride injection, USP 0.25% (2.5 mg/mL)
10 mL Single Dose Vials in a Carton of 25 NDC 55150-167-10
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Discard unused portion.
This container closure is not made with natural rubber latex.
Sterile, Nonpyrogenic

Distributed by:
AuroMedics Pharma LLC

279 Princeton-Hightstown Rd.
E. Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad — 500038
India
Revised: March 2019

Povidone-Iodine Swabsticks

Active Ingredient Purpose

Povidone Iodine 10% w/v (9.85% w/w) Antiseptic

Purpose:


Purpose:

  • First aid antiseptic to help prevent skin infection in minor cuts, scrapes and burns.
  • For preparation of the skin prior to surgery.
  • Helps reduce bacteria that can potentially cause skin infections.

Warnings:

  • FOR EXTERNAL USE ONLY

Do not use:

  • As a first aid antiseptic for more than 1 week.
  • In the eyes.
  • Over large areas of the body.

Ask a doctor before use if you have:

  • Deep puncture wounds
  • Animal bites
  • Serious burns

Stop Use:

  • If irritation and redness develop
  • If condition persists for more than 72 hours, consult a physician.

Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.


Directions Povidone iodine:

Tear at notch, remove applicator, use only once.

As a first aid antiseptic

  • clean affected area
  • apply 1 to 3 times daily
  • may be covered with a sterile bandage, if bandaged let dry.

For preoperative patient skin preparation

  • clean area
  • apply to operative site prior to surgery using the applicator

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

Isopropyl Alcohol 70% Prep Pads

Active ingredient

Isopropyl Alcohol 70% v/v

Purpose

Antiseptic

Uses

For first aid to decrease germs in

  • minor cuts
  • scrapes
  • burns

For preparation of the skin prior to injection

Warnings

For external use only

Flammable — keep away from fire or flame

Do not use

with electrocautery procedures

When using this product do not

  • get into eyes
  • apply over large areas of the body
  • in case of deep or puncture wounds, animal bites or serious burns consult a doctor

Stop use and ask a doctor if

  • condition persists or gets worse or lasts for more than 72 hours
  • do not use longer than 1 week unless directed by a doctor

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply to skin as needed
  • discard after single use

Other information

Protect from freezing and avoid excessive heat

Inactive ingredient

Water

PRINCIPAL DISPLAY PANEL

NDC: 76420-785-01

Rx Only

Marbeta-25™

Kit Contains

1 Bupivacaine HCl 0.25% Single Dose Vial (10mL)

1 Betamethasone Sodium Phosphate and Betamethasone Acetate 6mg/mL (5mL)

1 Povidone-Iodine Swabsticks (3 Swabs)

3 Isopropyl Alcohol 70% Prep Pads

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

Principal Display Panel
(click image for full-size original)
MARBETA 25 KIT betamethasone sodium phosphate and betamethasone acetate, bupivacaine hydrochloride, povidine iodine kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76420-785
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76420-785-01 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, MULTI-DOSE 5 mL
Part 2 1 VIAL, SINGLE-DOSE 10 mL
Part 3 1 PACKET 0.9 mL
Part 4 3 POUCH 15 mL
Part 1 of 4
BETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATE betamethasone sodium phosphate and betamethasone acetate injection, suspension
Product Information
Item Code (Source) NDC:0517-0720
Route of Administration INTRA-ARTICULAR, INTRAMUSCULAR, INTRALESIONAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETAMETHASONE SODIUM PHOSPHATE (BETAMETHASONE) BETAMETHASONE 3 mg in 1 mL
BETAMETHASONE ACETATE (BETAMETHASONE) BETAMETHASONE ACETATE 3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 7.1 mg in 1 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 3.4 mg in 1 mL
EDETATE DISODIUM 0.1 mg in 1 mL
BENZALKONIUM CHLORIDE 0.2 mg in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0517-0720-01 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (0517-0720-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090747 04/28/2010
Part 2 of 4
BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride injection, solution
Product Information
Item Code (Source) NDC:55150-167
Route of Administration EPIDURAL, INFILTRATION DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE) BUPIVACAINE HYDROCHLORIDE ANHYDROUS 2.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55150-167-10 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (55150-167-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203895 11/05/2013
Part 3 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 4 of 4
ISOPROPYL ALCOHOL isopropyl alcohol swab
Product Information
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 5 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 01/01/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/28/2010
Labeler — Asclemed USA, Inc. (059888437)

Revised: 09/2020 Asclemed USA, Inc.

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