POVIDONE IODINE WIPE- povidone-iodine swab

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

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02-02-2023

Werkstoffen:

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

Beschikbaar vanaf:

Jianerkang Medical Co., Ltd

Toedieningsweg:

TOPICAL

Prescription-type:

OTC DRUG

therapeutische indicaties:

First Aid Antiseptic First aid to help prevent infection in minorcuts, scraps, and burns Do not apply to persons allergic to iodine. Do not use in the eyes. Do not use if pouch is opened or damaged

Autorisatie-status:

OTC monograph final

Productkenmerken

                                POVIDONE IODINE WIPE- POVIDONE-IODINE SWAB
JIANERKANG MEDICAL CO., LTD
_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._
----------
EVER READY FIRST AID
POVIDONE IODINE WIPE
_ACTIVE INGREDIENTS_
Povidone-Iodine 10% w/v (equivalent to 1% titratable iodine)
_PURPOSE_
First Aid Antiseptic
_USES_
First aid to help prevent infection in minorcuts, scraps, and burns
_WARNINGS_
FOR EXTERNAL USE ONLY.
Do not apply to persons allergic to iodine. DO NOT USE in the eyes.
Do not use if pouch is opened or damaged
Ask a doctor before use if injuries are deep wounds, puncture wounds,
serious burns.
Keep out of reach of children
If swallowed or gets in eyes, get medical help or contact a Poison
Control Center right
away.
_DIRECTIONS_
Clean the affected area
Apply product on the area 1-3 times daily and discard
May be covered with a sterile bandage when dry
_INACTIVE INGREDIENTS_
Citric acid, Glycerin, Nonoxynol-10, Purified water, Sodium hydroxide
POVIDONE IODINE WIPE
povidone-iodine swab
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:34645-4011
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 100 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
NONOXYNOL-10 (UNII: K7O76887AP)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:34645-
4011-1
0.4 mL in 1 POUCH; Type 0: Not a Combination
Product
02/02/2023
Jianerkang Medical Co., Ltd
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC monograph final
part333C
02/02/2023
LABELER -
Jianerkang Medical Co., Ltd (530968767)
Revised: 2/
                                
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