POVIDONE IODINE- povidone-iodine spray 5% liquid

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

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Download 제품 특성 요약 (SPC)
15-12-2023

유효 성분:

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

제공처:

Humco Holding Group, Inc.

관리 경로:

TOPICAL

처방전 유형:

OTC DRUG

치료 징후:

- In the eyes - Over large areas of the body - If you are allergic to povidone-iodine or any other ingredients in this preparation - Deep or puncture wounds - Serious burns - Animal bites First aid to help prevent infection in minor - cuts - scrapes - burns Antiseptic

승인 상태:

OTC monograph not final

제품 특성 요약

                                POVIDONE IODINE- POVIDONE-IODINE SPRAY 5% LIQUID
HUMCO HOLDING GROUP, INC.
----------
PRIVATE LABEL POVIDONE IODINE SPRAY 5%
ACTIVE INGREDIENT
Povidone-Iodine 5%
(0.5% available iodine)
WARNINGS
For external use only.
DO NOT USE:
In the eyes
Over large areas of the body
If you are allergic to povidone-iodine or any other ingredients in
this preparation
ASK A DOCTOR BEFORE USE IF YOU HAVE:
Deep or puncture wounds
Serious burns
Animal bites
STOP AND ASK A DOCTOR IF:
The condition persists or gets worse
You need to use this product for more that 1 week
KEEP OUT OF REACH OF CHILDREN
If swallowed, get medical help or contact a Poison Control Center
right away.
OTHER INFORMATION
Store at 25°C (77°F); Excursions permitted between 15-30°C
(59-86°F). Do not freeze.
INACTIVE INGREDIENTS:
citric acid, disodium phosphate, glycerin, poloxamer 407, potassium
iodata, purified
water, sodium hydroxide.
DIRECTIONS:
Clean the affected area
Spray a small amount of product on the area 1 to 3 times daily
May be covered with a sterile bandage
If bandaged, let dry first
USES
First aid to help prevent infection in minor
cuts
scrapes
burns
PURPOSE
Antiseptic
Drug Facts
PRINCIPAL DISPLAY PANEL
POVIDONE IODINE
povidone-iodine spray 5% liquid
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:0395-9129
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
IODINE
50 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
POTASSIUM IODATE (UNII: I139E44NHL)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:0395-
9129-93
89 mL in 1 CONTAINER; Type 0: Not a Combination
Product
01/23/2020
MARKETING INFORMATION
MARKETING
APPLICATION NUMBER OR MONOGRAPH
MARKETING STAR
                                
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