POVIDONE-IODINE PREP PAD- povidone-iodine swab

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Davemed Healthcare Co., Ltd

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic for preparation of the skin. Non-sterile Solution Applicator is sterile if package is intact

Authorization status:

OTC monograph final

Summary of Product characteristics

POVIDONE-IODINE PREP PAD- POVIDONE-IODINE SWAB
DAVEMED HEALTHCARE 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._
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POVIDONE-IODINE
ACTIVE INGREDIENT
Povidone Iodine 10% w/w (equivalent to iodine 1%)
PURPOS E
Antiseptic
US E
Antiseptic for preparation of the skin.
Non-sterile Solution
Applicator is sterile if package is intact
WARNINGS
For external use only.
Discontinue use if irritation and redness develop.
Keep out of reach of Children.
DIRECTIONS
Apply locally as needed.
INACTIVE INGREDIENTS
Purified Water
POVIDONE-IODINE PREP PAD
povidone-iodine swab
Davemed Healthcare Co., Ltd
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:70 8 9 7-0 0 6
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
PO VIDO NE-IO DINE (UNII: 8 5H0 HZU9 9 M) (IODINE - UNII:9 6 79 TC0
7X4)
IODINE
0 .1 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:70 8 9 7-0 0 6 -0 1
1 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct
0 1/24/20 19
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph final
pa rt333C
0 1/24/20 19
LABELER -
Davemed Healthcare Co., Ltd (529128716)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
Davemed Healthcare Co ., Ltd
529 128 716
ma nufa c ture (70 8 9 7-0 0 6 )
Revised: 1/2019