BETADINE SOLUTION- povidone-iodine solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Atlantis Consumer Healthcare, Inc.

INN (Internationale Bezeichnung):

POVIDONE-IODINE

Zusammensetzung:

IODINE 10 mg in 1 mL

Verabreichungsweg:

TOPICAL

Verschreibungstyp:

OTC DRUG

Anwendungsgebiete:

Antiseptic Patient pre-operative skin preparation - for preparation of the skin prior to surgery - helps reduce bacteria that potentially can cause skin infection - in the eyes - if you are allergic to povidone-iodine or any other ingredientsin this preparation - irritation, sensitization, or allergic reaction occurs andlasts for 72 hours. These may be signs of a serious condition.

Produktbesonderheiten:

Other information

Berechtigungsstatus:

OTC monograph not final

Fachinformation

BETADINE SOLUTION- POVIDONE-IODINE SOLUTION
ATLANTIS CONSUMER HEALTHCARE, INC.
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BETADINE® SOLUTION
10% POVIDONE-IODINE
_DRUG FACTS_
_ACTIVE INGREDIENT_
Povidone-iodine, 10%(1% available iodine)
_PURPOSE_
Antiseptic
_USES_
PATIENT PRE-OPERATIVE SKIN PREPARATION
for preparation of the skin prior to surgery
helps reduce bacteria that potentially can cause skin infection
_WARNINGS_
FOR EXTERNAL USE ONLY
DO NOT USE
in the eyes
if you are allergic to povidone-iodine or any other ingredientsin this
preparation
WHEN USING THIS PRODUCT
single use will reduce the risk of infection from
extrinsiccontamination
prolonged exposure to wet solution may cause irritationor, rarely,
severe skin
reactions
in pre-operative prepping, avoid “pooling” beneath the patient
STOP USE AND ASK A DOCTORIF
irritation, sensitization, or allergic reaction occurs andlasts for 72
hours. These may
be signs of a serious condition.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison ControlCenter right
away.
_DIRECTIONS_
single use may prevent extrinsic contamination
clean the operative site prior to surgery
apply product and allow to dry
may be covered with a bandage
_OTHER INFORMATION_
store in original container
store at 25°C (77°F); excursions permitted between
15°-30°C(59°-86°F)
_INACTIVE INGREDIENTS_
pareth 25-9, purified water, sodium hydroxide
Dist. by:
AVRIO HEALTH L.P.
STAMFORD, CT 06901-3431
©2018, Avrio Health L.P.
BetadineSolution 8 oz
NDC: 67618-150-09
BETADINE SOLUTION
povidone-iodine solution
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:67618-150
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
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
C12-15 PARETH-9 (UNII: H3ZIY6WP1R)
Atlantis Consumer Healthcare, Inc.
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING S