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:

Hubei Chenteng Healthcare Co.,Ltd.

INN (International Name):

POVIDONE-IODINE

Composition:

IODINE 100 mg

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic To help prevent infection in minor cuts and scrapes.

Authorization status:

OTC monograph not final

Summary of Product characteristics

POVIDONE-IODINE PREP PAD- POVIDONE-IODINE SWAB
HUBEI CHENTENG 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._
----------
POVIDONE-IODINE PREP PAD
ACTIVE INGREDIENT:
Povidone-Iodine 10%w/w
(1% titratable iodine)
PURPOS E:
Antiseptic
US E
To help prevent infection in minor cuts and scrapes.
WARNINGS:
FOR EXTERNAL USE ONLY
SINGLE USE ONLY
DO NOT USE:
in the eyes
over large areas of the body
as a first aid antiseptic for longer than one week unless directed by
a physician
on individuals who are sensitive or allergic to iodine
if the package is damaged or open
CONSULT A PHYSICIAN IN CASE OF:
puncture or deep wounds
serious burns
animal bites
DIRECTIONS FOR USE:
Clean the treatment area
Apply to the treatment area or operative site before surgery
KEEP OUT OF REACH OF CHILDREN.
INACTIVE INGREDIENT
Purified water
PACKAGE LABEL
POVIDONE-IODINE PREP PAD
povidone-iodine swab
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:7150 9 -0 0 1
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
10 0 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:7150 9 -
0 0 1-0 0
1 in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System
(syringe, patch, etc.)
0 6 /22/20 17
0 4/30 /20 20
Hubei Chenteng Healthcare Co.,Ltd.
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph no t final
pa rt333A
0 6 /22/20 17
0 4/30 /20 22
LABELER -
Hubei Chenteng Healthcare Co.,Ltd. (544504326)
Revised: 5/2019