DYNAREX POVIDONE IODINE PREP SOLUTION- povidone iodine prep solution liquid

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Dynarex Corporation

Пут администрације:

TOPICAL

Тип рецептора:

OTC DRUG

Терапеутске индикације:

Healthcare Antiseptic For preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection

Статус ауторизације:

OTC monograph not final

Карактеристике производа

DYNAREX POVIDONE IODINE PREP SOLUTION- POVIDONE IODINE PREP
SOLUTION LIQUID
DYNAREX CORPORATION
_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._
----------
1413, 1414, 1415, 1416
_ACTIVE INGREDIENT_
Povidone-iodine 10%
_PURPOSE_
Healthcare Antiseptic
_USE_
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
if allergic to iodine
in the eyes
STOP USE AND ASK A DOCTOR IF
irritation and redness develop
condition persists for more than 72 hours
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or
contact a Poison
Control Center right away.
_DIRECTIONS_
Clean the area. Apply product to the operative site prior to surgery.
_OTHER_
Store at controlled room temperature.
_INACTIVE INGREDIENTS_
Citric Acid, Disodium Phosphate, Glycerin, Puried Water, Sodium
Citrate, Tween 80
_QUESTIONS?_
1-888-DYNAREX
_LABELING_
DYNAREX POVIDONE IODINE PREP SOLUTION
povidone iodine prep solution liquid
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:67777-141
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
GLYCERIN (UNII: PDC6A3C0OX)
Dynarex Corporation
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:67777-
141-31
48 in 1 CASE
05/08/2018
1
NDC:67777-
141-30
118 mL in 1 BOTTLE; Type 0: Not a Combination
Product
2
NDC:67777-
141-41
24 in 1 CASE
05/08/2018
2
NDC:67777-
141-40
237 mL in 1 BOTTLE; Type 0: Not a Combination
Product
3
NDC:67777-
141-51
24 in 1 C