POVIDONE IODINE- povidone-iodine swab 
Yinjing Medical Technology (Shanghai) 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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POVIDONE-IODINE SWABSTICK

Drug Facts


Active Ingredients

Povidone-Iodine 10% w/w
(1% titratable iodine)

Purpose

Antiseptic

Use

First aid antiseptic to help prevent infection in scrapes, minor cuts and burns Antiseptic to prepare skin prior to surgery. Uses antiseptic skin preparation

Stop Use Section

Stop use and ask a doctor if skin irritation, redness, swelling, or pain occurs.

Warnings Section

Warnings • Do not use if allergic to iodine • For external use only • Do not use in eyes • Avoid pooling beneath patient • In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Keep Out of Reach of Children Section

Keep out of reach of children.

Directions Section

Directions apply locally as needed

Inactive Ingredients Section

Inactive ingredients Sodium hydroxide, water

Other Information Section

Other information
For Hospital or Professional Use Only.
Store at room temperature: 15℃- 30 ℃

For professional and hospital use
Store at room temperature
LOT                           EXP.

IN IN
NDC:44019-236-01

POVIDONE-IODINE SWABSTICK

For External Use Only

1 swabstick/packet

Product Label

Povidone-iodine Swabstick(1pack)Povidone-iodine swabstick(3pack)

POVIDONE IODINE 
povidone-iodine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44019-236
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44019-236-011 in 1 PACKET08/03/2016
11.6 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:44019-236-033 in 1 PACKET08/03/2016
25 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/03/2016
Labeler - Yinjing Medical Technology (Shanghai) Co., Ltd. (530501535)
Registrant - Yinjing Medical Technology (Shanghai) Co., Ltd. (530501535)

Revised: 12/2017
Document Id: 61964a72-6962-a6dc-e053-2991aa0a8349
Set id: f69a9a2c-39d0-4b05-ab98-b8b8f9884c43
Version: 4
Effective Time: 20171230
 
Yinjing Medical Technology (Shanghai) Co., Ltd.