MK MAOKANG MEDICAL POVIDONE IODINE SWABSTICKS- 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:
Changzhou Maokang Medical Products Co., Ltd
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
for antiseptic skin preparation
Authorization status:
OTC monograph not final
Authorization number:
59050-259-10

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MK MAOKANG MEDICAL POVIDONE IODINE SWABSTICKS- povidone-iodine swab

Changzhou Maokang Medical Products Co., Ltd

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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MK MaoKang Medical Povidone- Iodine Swabsticks 3 each

Drug Facts

Active ingredient

Povidone-lodine USP10%

Purpose

Antiseptic

Use

for antiseptic skin preparation

Warnings

do not use

if allergic to Iodine

do not use in the eye

Stop use and ask a doctor if

redness,irritation,swelling or pain persists or increases

infection occurs

Keep out of reach of children.

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

immediately.

Avoid pooling beneath patient.

Ask a doctor before use if injuries are

deep or puncture wounds

serious burns

Directions

apply locally as needed

Other information

1% titratable iodine

for hospital or professional use only

Inactive ingredients:

Citric Acid,Alkyl Glucoside,Hydroxyethyl Cellulose,Nonoxynol-

10,Glycerin,Sodium Hydroxide,Potassium lodide,Purified Water.

Package Labeling:

MK MAOKANG MEDICAL POVIDONE IODINE SWABSTICKS

povidone-iodine swab

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:59 0 50 -259

Route of Administration

TOPICAL

Changzhou Maokang Medical Products Co., Ltd

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

C12 -2 0 ALKYL GLUCO SIDE (UNII: K6 7N5Z1RUA)

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

HYDRO XYETHYL CELLULO SE, UNSPECIFIED (UNII: T4V6 TWG28 D)

NO NO XYNO L-10 (UNII: K7O76 8 8 7AP)

GLYCERIN (UNII: PDC6 A3C0 OX)

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

PO TASSIUM IO DIDE (UNII: 1C4QK22F9 J)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:59 0 50 -259 -10

1 in 1 POUCH

11/11/20 20

1

3 in 1 PACKAGE

1

1.8 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 rt333E

11/11/20 20

Labeler -

Changzhou Maokang Medical Products Co., Ltd (421317073)

Revised: 11/2020

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