POVIDONE-IODINE PAD- povidone-iodine swab

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M)

Available from:

Shandong Haiyan Medical Manufacture Co., Ltd.

INN (International Name):

POVIDONE-IODINE

Composition:

POVIDONE-IODINE 9.43 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph final

Summary of Product characteristics

POVIDONE-IODINE PAD - POVIDONE-IODINE SWAB
SHANDONG HAIYAN MEDICAL MANUFACTURE 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._
----------
ANTISEPTIC POVIDONE-IODINE PREP PAD 10% POVIDONE-IODINE, 1% AVAILABLE
IODINE. SHANDONG
HAIYAN MEDICAL MANUFACTURE CO., LTD. WWW. HAIYAN-MEDICAL.COM
ACTIVE INGREDIENT
Povidone Iodine 10% w/w (equivalent to iodine 1%)
PURPOS E
Antiseptic
US E
Antiseptic for preparation of the skin.
WARNINGS
For external use only.
Discontinue use if irritation and redness develop.
Keep out of reach of Children.
DIRECTIONS
Apply locally as needed.
Other Information
Store at room temperature: 59°- 86°F(15 - 30 )
INACTIVE INGREDIENTS
Purified Water
Shandong Haiyan Medical Manufacture Co., Ltd.
POVIDONE-IODINE PAD
povidone-iodine swab
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:42339 -0 0 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) (POVIDONE-IODINE - UNII:8
5H0 HZU9 9 M)
POVIDONE-IODINE
9 .43 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)
SO DIUM PHO SPHATE (UNII: SE337SVY37)
WATER (UNII: 0 59 QF0 KO0 R)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:42339 -0 0 2-0 1
10 in 1 CONTAINER
1
10 0 in 1 BOX
1
0 .6 g in 1 POUCH
2
NDC:42339 -0 0 2-0 2
10 0 in 1 CONTAINER
2
10 0 in 1 BOX
2
0 .6 g in 1 POUCH
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
0 2/18 /20 12
LABELER -
Shandong Haiyan Medical Manufacture Co., Ltd. (421283439)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
Shando ng Haiyan Medical Manufacture Co ., Ltd.
42128 3439
ma nufa c ture
Revised: 3/2012