POVIDONE-IODINE SCRUB SOLUTION- povidone-iodine solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Changzhou Maokang Medical Products Co., Ltd

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

for antiseptic skin preparation

Authorization status:

OTC monograph not final

Summary of Product characteristics

POVIDONE-IODINE SCRUB SOLUTION- POVIDONE-IODINE SOLUTION
CHANGZHOU MAOKANG MEDICAL PRODUCTS CO., LTD
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POVIDONE-IODINE SCRUB SOLUTION
_DRUG FACTS_
_ACTIVE INGREDIENT_
Povidone-Iodine 7.5%w/w
_PURPOSE_
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 persist or increases
infection occurs
KEEP OUT OF REACH OF CHILDREN.
In case of accidental ingestion, seek professional assistance or
consult a Poison Control
Center immediately.
_AVOID POOLING BENEATH PATIENT._
_DIRECTIONS_
apply locally as needed
_OTHER INFORMATION_
0.75% titratable iodine
for hospital or professional use only
_INACTIVE INGREDIENTS:_
Hydroxyethyl cellulose, nonoxynol-10, alkyl glucoside, potassium
iodide, sodium
hydroxide, glycerin, citric acid, purifed water
PACKAGE LABELING:
POVIDONE-IODINE SCRUB SOLUTION
povidone-iodine solution
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:59050-559
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
IODINE
75 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
NONOXYNOL-10 (UNII: K7O76887AP)
POTASSIUM IODIDE (UNII: 1C4QK22F9J)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERIN (UNII: PDC6A3C0OX)
Changzhou Maokang Medical Products Co., Ltd
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:59050-559-
64
118 mL in 1 BOTTLE; Type 0: Not a Combination
Product
06/10/2020
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC Monograph Drug
505G(a)(3)
06/10/2020
LABELER -
Changzhou Maokang Medical Products Co., Ltd (421317073)
Revised: 11/2023