POVIDONE IODINE IMPREGNATED- povidone iodine sponge

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

Povidone Iodine, USP 7.5% (0.75% available Iodine)

Dostępny od:

Jianerkang Medical Co., Ltd

Droga podania:

TOPICAL

Typ recepty:

OTC DRUG

Wskazania:

Antiseptic For preparation of skin and mucous membranes prior to surgery Skin shows symptoms of irritation, sensitivity, redness, pain or swelling

Status autoryzacji:

OTC monograph not final

Charakterystyka produktu

POVIDONE IODINE IMPREGNATED- POVIDONE IODINE SPONGE
JIANERKANG MEDICAL CO., LTD
----------
IMPREGNATED WINGED SPONGES - TWO SPONGES STICKS IMPREGNATED WITH 100ML
PROVIDONE IODINE (SCRUB)
ACTIVE INGREDIENTS
Povidone Iodine, USP 7.5% (0.75% available Iodine)
PURPOSE
Antiseptic
USES
For preparation of skin and mucous membranes prior to surgery
WARNINGS
For external use only
Avoid use on persons allergic to iodine
STOP USE AND ASK A DOCTOR IF
Skin shows symptoms of irritation, sensitivity, redness, pain or
swelling
KEEP OUT OF REACH OF CHILDREN
If swallowed, get medical help or contact Poison Control Center right
away
DIRECTIONS
open pouch at tear notch
use sponge sticks to prep desired area
OTHER INFORMATION
store at room temperature avoid excessive heat (above 104 F/40 C)
protect from
freezing latex free
oo
INACTIVE INGREDIENTS
purified water, hydroxyethylcellulose, Nonylph
PACKAGE LABEL
POVIDONE IODINE IMPREGNATED
povidone iodine sponge
PRODUCT INFORMATION
Jianerkang Medical Co., Ltd
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:34645-1032
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
IODINE
7.5 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:34645-
1032-1
10 in 1 BOX
03/03/2015
1
100 mL 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 Drug
505G(a)(3)
03/03/2015
LABELER -
Jianerkang Medical Co., Ltd (530968767)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Jianerkang Medical Co., Ltd
530968767
manufacture(34645-1032)
Revised: 10/2023