POVIDONE-IODINE PREP PADS MEDIUM- povidone-iodine cloth POVIDONE-IODINE PREP PADS MEDIUM BULK- povidone-iodine cloth

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Medline Industries, LP

INN (International Name):

POVIDONE-IODINE

Composition:

IODINE 10 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic - First aid antiseptic to help prevent infection in minor cuts, scrapes and burns

Authorization status:

OTC monograph not final

Summary of Product characteristics

POVIDONE-IODINE PREP PADS MEDIUM- POVIDONE-IODINE CLOTH
POVIDONE-IODINE PREP PADS MEDIUM BULK- POVIDONE-IODINE CLOTH
MEDLINE INDUSTRIES, LP
_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._
----------
940-941 POVIDONE-IODINE PREP PADS
_ACTIVE INGREDIENT_
Povidone-Iodine, 10% w/w
_PURPOSE_
Antiseptic
_USES_
First aid antiseptic to help prevent infection in minor cuts, scrapes
and burns
_WARNINGS_
FOR EXTERNAL USE ONLY.
DO NOT USE
in the eyes
longer than 1 week unless directed by a physician
on individuals who are allergic or sensitive to iodine
or apply over large areas of the body
STOP USE AND ASK A DOCTOR IF
irritation and redness develop
condition persists for more than 72 hours
in case of deep or puncture wounds, animal bites or serious burns
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical assistance or immediately contact a Poison
Control Center.
_DIRECTIONS_
clean the affected area
apply a small amount of this product on the area 1 to 3 times daily.
may be covered with a sterile bandage
if bandaged, let dry first
_OTHER INFORMATION_
do not flush
protect from freezing, avoid excessive heat
_INACTIVE INGREDIENTS_
citric acid, disodium phosphate, water
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
POVIDONE-IODINE PREP PADS MEDIUM
povidone-iodine cloth
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:53329-941
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
IODINE
10 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:53329-941-
30
100 in 1 BOX
01/11/2019
1
NDC:53329-941-
09
1 mL in 1 PACKET