BETADINE SOLUTION SWABSTICKS- povidone-iodine solution

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Atlantis Consumer Healthcare, Inc.

INN (International Nazwa):

POVIDONE-IODINE

Skład:

POVIDONE-IODINE .01 mL

Droga podania:

TOPICAL

Typ recepty:

OTC DRUG

Wskazania:

Povidone-iodine Solution USP, 10% (equal to1% available iodine) Antiseptic - for preparation of the skin prior to surgery - helps reduce bacteria that can potentially cause skin infection - in the eyes - if you are allergic to iodine or other product ingredients

Status autoryzacji:

OTC monograph not final

Charakterystyka produktu

BETADINE SOLUTION SWABSTICKS- POVIDONE-IODINE SOLUTION
ATLANTIS CONSUMER HEALTHCARE, INC.
----------
BETADINE® SOLUTION SWABSTICK
POVIDONE-IODINESOLUTION USP, 10%
DRUG FACTS
ACTIVE INGREDIENT PURPOSE
Povidone-iodine Solution USP, 10% (equal to1% available iodine)
PURPOSE
Antiseptic
USES
for preparation of the skin prior to surgery
helps reduce bacteria that can potentially cause skin infection
WARNINGS
FOR EXTERNAL USE ONLY
DO NOT USE THIS PRODUCT
in the eyes
if you are allergic to iodine or other product ingredients
WHEN USING THIS PRODUCT
prolonged exposure may cause irritation or, rarely, severeskin
reactions
STOP USING THIS PRODUCT
in rare instances of local irritation or sensitivity
if irritation and redness develop and continue for morethan 72 hours
KEEP OUT OF REACH OFCHILDREN.
Ifswallowed, get medical help or contact a Poison Control Center
rightaway
DIRECTIONS
tear at slit; pull top of packette across, exposing endof swabstick
remove Betadine Solution Swabstick and apply as needed
use one time only
OTHER INFORMATION
store between 20˚-25˚C (68˚-77˚F).Avoid freezing and excessive
heat above 40˚C
(104˚F).
INACTIVE INGREDIENTS
purified water, sodium hydroxide
Dist. by:
AVRIO HEALTH L.P.
STAMFORD, CT 06901-3431
BetadineSwabsticks — 1 Swab
NDC: 67618-153-01
BetadineSwabsticks — 3 Swabs
67618-153-03
BETADINE SOLUTION SWABSTICKS
povidone-iodine solution
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:67618-153
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 HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
PACKAGING
Atlantis Consumer Healthcare, Inc.
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:67618-
153-01
1 in 1 POUCH
09/15/1972
1
1.9 mL in 1 APPLICATOR; Type 0: Not a
Combination Product
2
NDC:67618-
153-03
3 in 1 POUCH
09/15/1972
2
1.9 mL in 1 APP