POVIDONE IODINE swab

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Povidone-Iodine (UNII: 85H0HZU99M) (Povidone-Iodine - UNII:85H0HZU99M)

Available from:

Dalian Rongbang Medical Healthy Devices Co

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Clean intended area thoroughly with pad. discard after single use. Clean intended area.

Authorization status:

OTC monograph final

Summary of Product characteristics

POVIDONE IODINE - POVIDONE IODINE SWAB
DALIAN RONGBANG MEDICAL HEALTHY DEVICES CO
_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 PAD
10% povidone-iodine solution equivalent to 1% available iodine.
not listed on label
1 pad. for external use only
Clean intended area thoroughly with pad. discard after single use.
for professional and hospital use.
store at room temperature. In case of deep or puncture wounds or
serious burns, and if pain, irritation,
redness, swellling, or infection occurs, discontinue use and contact a
physician. See drug facts panel on
box. For external use only.
Clean intended area.
Rongbang Antiseptic, Povidone-Iodine, USP, Prep Pad, Medium
Dalian Rongbang Medical Healthy Devices Co
POVIDONE IODINE
povidone iodine swab
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:49 9 53-28 0 5
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) (Po vido ne-Io dine - UNII:8
5H0 HZU9 9 M)
Po vido ne -Io dine
1 mL in 10 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WA TER (UNII: 0 59 QF0 KO0 R)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:49 9 53-28 0 5-1
1 mL in 1 POUCH
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 7/0 2/20 10
LABELER -
Dalian Rongbang Medical Healthy Devices Co (529882730)
REGISTRANT -
Dalian Rongbang Medical Healthy Devices Co (529882730)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
Dalian Ro ngbang Medical Healthy Devices Co
529 8 8 2730
ma nufa c ture
Revised: 7/2010