DUAL SWAB POVIDONE-IODINE PREP- povidone iodine kit

United States - English - NLM (National Library of Medicine)

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Active ingredient:
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
Available from:
Dynarex Corporation
Prescription type:
OTC DRUG
Therapeutic indications:
Uses Povidone Iodine Scrub Swabstick - For scrubbing procedure site, prior to antiseptic application. Povidone Iodine Prep Swabstick - For antiseptic application at procedure site. Indications and Usage - For pre-operative patient skin preparation. Stop use and ask a healthcare professional if; - condition worsens or persists for more than 72 hours - if pain, irritation, redness or swelling occurs Do Not Use: - as a first aid antiseptic for more than 1 week - over large areas of the body
Authorization status:
OTC monograph final
Authorization number:
67777-302-01, 67777-303-01, 67777-414-01

DUAL SWAB POVIDONE-IODINE PREP- povidone iodine

Dynarex Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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1205 Dynarex Dual Prep and Scrub Swabstick NDC 67777-302-01

Active Ingredient Purpose

Povidone Iodine Scrub 7.5% w/w Antiseptic

Povidone Iodine Prep 10% w/w Antiseptic

Purpos e

Us es

Povidone Iodine Scrub Swabstick - For scrubbing procedure site, prior to antiseptic application.

Povidone Iodine Prep Swabstick - For antiseptic application at procedure site.

Indications and Usage

For pre-operative patient skin preparation.

Warnings

For External Use Only

Avoid contact with eyes. If contact occurs, flush with water.

Stop Use

Stop use and ask a healthcare professional if;

condition worsens or persists for more than 72 hours

if pain, irritation, redness or swelling occurs

Ask a Doctor

Ask a doctor before use if you have:

deep puncture wounds

animal bites

serious wounds

Do Not Use:

as a first aid antiseptic for more than 1 week

over large areas of the body

Keep Out Of Reach Of Children

if swallowed, get medical help or contact a Poison Control Center immediately .

Dosage and Administration

Directions

For pre-operative patient skin preparation:

Apply to procedure site and allow to dry.

discard after single use.

If not ready for immediate venipuncture, cover the area with a dry sterile gauze.

As a first aid antiseptic:

clean affected area

apply to wound once or twice daily

may be covered with a sterile bandage

if bandaged let dry first

Tear at notch, remove applicator, use only once.

Inactive Ingredients

Povidone Iodine 7.5% Scrub Solution - Lauramide DEA, water

Povidone Iodine 10% Prep Solution - Anhydrous citric acid, disodium hydrogen phosphate, water

Other information

Store at room temperature

Avoid excessive heat

Principal Display panel

Dynarex Dual Swab Prep and Scrub Kit

Item 1207

1207_pouches.jpg

DUAL SWAB POVIDONE-IODINE PREP

povidone iodine kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 7777-414

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 7777-414-0 1

1 in 1 PACKAGE; Type 1: Co nvenience Kit o f Co -Package

0 4/0 5/20 17

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

25 POUCH

32.5 mL

Pa rt 2

25 POUCH

32.5 mL

Part 1 of 2

DUAL SWAB POVIDONE-IODINE PREP

povidone iodine swab

Product Information

Ite m Code (Source )

NDC:6 7777-30 2

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PO VIDO NE-IO DINE (UNII: 8 5H0 HZU9 9 M) (IODINE - UNII:9 6 79 TC0 7X4)

IODINE

7.5 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

LAURIC DIETHANO LAMIDE (UNII: I29 I2VHG38 )

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:6 7777-30 2-

1.3 mL in 1 POUCH; Type 1: Co nvenience Kit o f Co -

Pa c ka ge

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt333C

Part 2 of 2

DUAL SWAB POVIDONE-IODINE PREP

povidone iodine swab

Product Information

Ite m Code (Source )

NDC:6 7777-30 3

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PO VIDO NE-IO DINE (UNII: 8 5H0 HZU9 9 M) (IODINE - UNII:9 6 79 TC0 7X4)

IODINE

10 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

SO DIUM PHO SPHATE, DIBASIC DO DECAHYDRATE (UNII: E1W4N241FO)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:6 7777-30 3-

1.3 mL in 1 POUCH; Type 1: Co nvenience Kit o f Co -

Pa c ka ge

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt333C

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt333C

11/15/20 15

Labeler -

Dynarex Corporation (008124539)

Dynarex Corporation

Registrant -

Dynarex Corporation (008124539)

Revised: 1/2020

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