POVIDONE IODINE PREP- povidone iodine swab

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

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Active ingredient:
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
Available from:
PHOENIX HEALTHCARE SOLUTIONS, LLC
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic - Health-care antiseptic for preparation of the skin prior to surgery - First aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes and burns
Authorization status:
OTC monograph not final
Authorization number:
60913-999-02

POVIDONE IODINE PREP - povidone iodine swab

PHOENIX HEALTHCARE SOLUTIONS, LLC

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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Drug Facts

Active ingredient

Povidone Iodine USP 10% v/v

Purpos e

Antiseptic

Us es

Health-care antiseptic for preparation of the skin prior to surgery

First aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes and burns

Warnings :

For external use only

Do not

use in the eyes

use on individuals who are allergic or sensitive to iodine

apply over large areas of the body

use as a first aid antiseptic longer than 1 week unless directed by a doctor.

Discontinue use if irritation and redness develop.

Consult a doctor in case of

deep or puncture wounds

animal bites

serious burns

Stop use and consult a doctor

if the condition persists or gets worse.

Keep out of reach of children

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

Directions :

For preparation of the skin prior to surgery

clean the affected area

apply a small amount of this product on the area

For use as a first aid antiseptic

clean the affected area

apply a small amount of this product on the area 1-3 times daily

may be covered with a sterile bandage

if bandaged, let dry first.

Other information

Store at room temperature: 59 - 86 F (15 - 30 C)

Inactive ingredients:

citric acid, glycerin, Makon 8, purified water, sodium hydroxide

Principal Display Panel

Phoenix Healthcare Solutions LLC

An Innovative Medical Manufacturer

NDC 60913-999-02

200 Individual Pads

Povidone Iodine Prep Pads

Medium

For Individual, Professional and Hospital Use

Saturated with 10% Povidone Iodine for external use only

Latex Free

PIN DOT WOVEN

POVIDONE IODINE PREP

povidone iodine swab

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 0 9 13-9 9 9

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

PHOENIX HEALTHCARE SOLUTIONS, LLC

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

1 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

GLYCERIN (UNII: PDC6 A3C0 OX)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 0 9 13-9 9 9 -0 2

20 0 in 1 CARTON

0 2/26 /20 15

1

1 mL in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

0 2/26 /20 15

Labeler -

PHOENIX HEALT HCARE SOLUT IONS, LLC (079146847)

Revised: 2/2020

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