POVIDONE-IODINE PREP PAD- povidone-iodine solution

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Cardinal Health 200, Inc.

Пут администрације:

TOPICAL

Тип рецептора:

OTC DRUG

Терапеутске индикације:

•first aid to help prevent skin infection in minor cuts, scrapes, and burns

Статус ауторизације:

OTC monograph not final

Карактеристике производа

POVIDONE-IODINE PREP PAD- POVIDONE-IODINE SOLUTION
CARDINAL HEALTH 200, INC.
----------
POVIDONE-IODINE PREP PAD
DRUG FACTS
_ACTIVE INGREDIENT_
Povidone-Iodine USP 10% (equivalent to 1% titratable iodine)
_PURPOSE_
First Aid Antiseptic
_USE_
•first aid to help prevent skin infection in minor cuts, scrapes,
and burns
_WARNINGS_
For external use only. Do not apply to persons allergic to Iodine
ALLERGY ALERT:
DO NOT USE
• in the eyes or apply over large areas of the body • longer than
one week unless
directed by a doctor
ASK A DOCTOR BEFORE USE IF YOU HAVE
• deep or puncture wounds • animal bites • serious burns
STOP USE AND CONSULT A DOCTOR
if the condition persists or gets worse
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
_DIRECTIONS_
• clean the affected area • apply a small amount of this product
on the area 1-3 times
daily • may be covered with a sterile bandage • if bandaged, let
dry first
_OTHER INFORMATION_
• store at 15°-30°C (59°-86°F)
_INACTIVE INGREDIENTS_
(purified) water, glycerol, nonylphenol ethoxylate, citric acid,
sodium hydroxide
PACKAGE LABELING:
PACKET LABELING:
BOX LABELING:
CARTON LABELING:
POVIDONE-IODINE PREP PAD
povidone-iodine solution
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:63517-400
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
IODINE
10 g in 100 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PACKAGING
#
ITEM
CODE
PACKAGE DESCRIPTION
MARKETING
START DATE
MARKETING
END DATE
1
NDC:63517-
400-83
10 in 1 CARTON
08/05/2016
1
100 in 1 BOX
1
0.56 g in 1 POUCH; Type 2: Prefilled Drug Delivery
Device/System (syringe, patch, etc.)
Cardinal Health 200, Inc.
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAP