BETADINE CREAM- povidone-iodine cream

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.

Droga podania:

TOPICAL

Typ recepty:

OTC DRUG

Wskazania:

Purpose First aid antiseptic Uses First aid to help prevent infection in minor - cuts - scrapes - burns

Podsumowanie produktu:

Other information

Status autoryzacji:

OTC monograph not final

Charakterystyka produktu

BETADINE CREAM- POVIDONE-IODINE CREAM
ATLANTIS CONSUMER HEALTHCARE INC.
_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._
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BETADINE® CREAM
5% POVIDONE-IODINE
_DRUG FACTS_
_ACTIVE INGREDIENT_
Povidone-iodine, 5% (0.5% available iodine)
_PURPOSE_
First aid antiseptic
_USES_
First aid to help prevent infection in minor
cuts
scrapes
burns
_WARNINGS_ FOR EXTERNALUSE ONLY
DO NOT USE
in the eyes
over large areas of the body
if you are allergic to povidone-iodine or any other ingredientsin this
preparation
ASK A DOCTOR BEFOREUSE IF YOU HAVE
deep or puncture wounds
serious burns
animal bites
STOP USE AND ASKA DOCTOR IF
the condition persists or gets worse
you need to use this product for more than 1 week
KEEP OUT OF REACH OF CHILDREN.
If swallowed, getmedical help or contact a Poison Control Center right
away
_DIRECTIONS_
clean the affected area
apply a small amount of product (equal to the surface areaof a
fingertip) to the area
1 to 3 times daily
may be covered with a sterile bandage
_OTHER INFORMATION_
store at 25°C (77°F); excursions permitted between
15°-30°C(59°-86°F)
_INACTIVE INGREDIENTS_
cetostearyl alcohol,glycerin, mineral oil, PEG-50stearate, polysorbate
60, potassium
iodate, sodium hydroxide, sorbitanmonostearate, water, white
petrolatum
Dist. by:
AVRIO HEALTHL.P.
STAMFORD, CT 06901-3431
305099-0B
BetadineCream
NDC: 67618-180-12
BETADINE CREAM
povidone-iodine cream
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:67618-180
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
IODINE
0.05 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)
PEG-50 STEARATE (UNII: 776CJK5X56)
POLYSORBATE 60 (UNII: CAL22