POVIDONE-IODINE SOLUTION STERILE- povidone-iodine liquid

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Changzhou Maokang Medical Products Co., Ltd

Indgivelsesvej:

TOPICAL

Recept type:

OTC DRUG

Terapeutiske indikationer:

for antiseptic skin preparation

Autorisation status:

OTC monograph not final

Produktets egenskaber

POVIDONE-IODINE SOLUTION STERILE- POVIDONE-IODINE LIQUID
CHANGZHOU MAOKANG MEDICAL PRODUCTS CO., LTD
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POVIDONE-IODINE SOLUTION STERILE
DRUG FACTS
_ACTIVE INGREDIENT_
Povidone-Iodine 10%USP
_PURPOSE_
First aid antiseptic
_USE_
for antiseptic skin preparation
_WARNINGS_
DO NOT USE
if allergic to Iodine
do not use in the eye
STOP USE AND ASK A DOCTOR IF
redness, irritation, swelling or pain persists or increases
infection occurs
KEEP OUT OF REAVH OF CHILDREN.
In case of accidental ingestion, seek professional assistance or
consult a poison control
center immediately.
Avoid pooling beneath patient.
ASK A DOCTOR BEFORE USE IF INJURIES ARE
deep or punture wounds
serious burns
_DIRECTIONS_
Apply product to skin as needed.
_OTHER INFORMATION_
1% titratable iodine
for hospital or professional use only
_INACTIVE INGREDIENTS:_
Citric Acid,Alkyl Glucoside,Hydroxyethyl
cellulose,Nonoxynol-10,Glycerin,Sodium
Hydroxide,Potassium Iodide, Purified Water.
PACKAGE LABELING:
POVIDONE-IODINE SOLUTION STERILE
povidone-iodine liquid
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:59050-554
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
IODINE
100 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
NONOXYNOL-10 (UNII: K7O76887AP)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POTASSIUM IODIDE (UNII: 1C4QK22F9J)
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
Changzhou Maokang Medical Products Co., Ltd
1
NDC:59050-554-
11
30 mL in 1 POUCH; Type 0: Not a Combination
Product
10/22/2019
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC Monograph Drug
505G(a)(3)
10/22/2019
LABELER -
Changzhou Maokang Medical Products Co., Ltd (421317073)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Ch