POVIDONE-IODINE PAD- povidone-iodine swab

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)

থেকে পাওয়া:

Shandong Haiyan Medical Manufacture Co., Ltd.

প্রশাসন রুট:

TOPICAL

প্রেসক্রিপশন টাইপ:

OTC DRUG

থেরাপিউটিক ইঙ্গিত:

Antiseptic for preparation of the skin.

অনুমোদন অবস্থা:

OTC monograph final

পণ্য বৈশিষ্ট্য

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._
----------
42339-003 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%)
PURPOSE
Antiseptic
USE
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
POVIDONE-IODINE PAD
povidone-iodine swab
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:42339-003
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
IODINE
9.43 g in 100 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE (UNII: SE337SVY37)
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:42339-003-
01
10 in 1 CONTAINER
02/18/2012
1
100 in 1 BOX
1
0.6 g in 1 POUCH; Type 0: Not a Combination
Product
2
NDC:42339-003-
02
100 in 1 CONTAINER
02/18/2012
2
100 in 1 BOX
2
0.6 g in 1 POUCH; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC monograph final
part333C
02/18/2012
LABELER -
Shandong Haiyan Medical Manufacture Co., Ltd. (421283439)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Shandong Haiyan Medical Manufacture Co., Ltd.
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Shandong Haiyan Medical Manufacture Co., L