POVIDONE IODINE- povidone-iodine swab

POVIDONE IODINE by

Drug Labeling and Warnings

POVIDONE IODINE by is a Otc medication manufactured, distributed, or labeled by Yinjing Medical Technology (Shanghai) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 ℃

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

IN IN
NDC: 44019-236-01

POVIDONE-IODINE SWABSTICK

For External Use Only

1 swabstick/packet

Product Label

INGREDIENTS AND APPEARANCE

POVIDONE IODINE 
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44019-236
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44019-236-01	1 in 1 PACKET	08/03/2016
1		1.6 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 44019-236-03	3 in 1 PACKET	08/03/2016
2		5 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/03/2016

Labeler - Yinjing Medical Technology (Shanghai) Co., Ltd. (530501535)

Registrant - Yinjing Medical Technology (Shanghai) Co., Ltd. (530501535)