POVIDONE-IODINE PREP WINGED STERILE SMALL- povidone-iodine sponge

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Cardinal Health 200 LLC

administration_route:

TOPICAL

prescription_type:

OTC DRUG

therapeutic_indication:

• For preparation prior to surgery • Helps to reduce bacteria that can potentially cause skin infection.

authorization_status:

OTC monograph not final

SPC

POVIDONE-IODINE PREP WINGED STERILE SMALL- POVIDONE-IODINE SPONGE
CARDINAL HEALTH 200 LLC
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POVIDONE-IODINE PREP WINGED SPONGES STERILE SMALL
DRUG FACTS
ACTIVE INGREDIENT
Povidone-Iodine USP 10%
PURPOSE
Antiseptic
USE
• For preparation prior to surgery • Helps to reduce bacteria that
can potentially cause
skin infection.
WARNINGS
For external use only.
DO NOT APPLY TO PERSONS ALLERGIC TO IODINE
DO NOT USE
• in the eyes
ASK A DOCTOR BEFORE USE IF INJURIES ARE
• deep wounds • puncture wounds • serious burns
STOP USE AND ASK A DOCTOR IF
• irritation and redness develop • condition persists for more
than 72 hours • infection
occurs
AVOID POOLING BENEATH THE PATIENT.
Prolonged exposure to wet solution may cause skin irritation.
KEEP OUT OF REACH OF CHILDREN.
If swallowed or gets in eyes, get medical help or contact a Poison
Control Center right
away.
DIRECTIONS
Clean the area. Apply product to the operative site prior to surgery
using sponge sticks
to prep desired area.
OTHER INFORMATION
• saturating solution contains 1% titratable iodine • latex free
• for hospital or
professional use only
INACTIVE INGREDIENTS
Citric Acid, Alkyl Glucoside, Hydroxyethyl Cellulose, Nonoxynol-10,
Glycerin, Sodium
Hydroxide, Potassium Iodide, Purified Water
PRODUCT LABEL
POVIDONE-IODINE PREP WINGED STERILE SMALL
Cardinal Health 200 LLC
povidone-iodine sponge
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:63517-751
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 g
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
1
NDC:63517-
751-11
100 g in 1 POUCH; Type 4: Device
Coated/