Povidone Iodine Swab [Dalian Rongbang Medical Healthy Devices Co] -

POVIDONE IODINE SWAB [DALIAN RONGBANG MEDICAL HEALTHY DEVICES CO]
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NDC	49953-2805-1
Set ID	261fac31-d470-4346-880b-a69e80330b14
Category	HUMAN OTC DRUG LABEL
Packager	Dalian Rongbang Medical Healthy Devices Co
Generic Name
Product Class	Antiseptic
Product Number
Application Number	PART333C

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ACTIVE INGREDIENT

10% povidone-iodine solution equivalent to 1% available iodine.
INACTIVE INGREDIENT

not listed on label
DOSAGE & ADMINISTRATION

1 pad. for external use only
INDICATIONS & USAGE

Clean intended area thoroughly with pad. discard after single use.
KEEP OUT OF REACH OF CHILDREN

for professional and hospital use.
WARNINGS

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.
PURPOSE

Clean intended area.
PRINCIPAL DISPLAY PANEL

Rongbang Antiseptic, Povidone-Iodine, USP, Prep Pad, Medium

INGREDIENTS AND APPEARANCE

POVIDONE IODINE
povidone iodine swab

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Povidone-Iodine (UNII: 85H0HZU99M) (Povidone-Iodine - UNII:85H0HZU99M)	Povidone-Iodine	1 mL in 10 mL

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49953-2805-1	1 mL in 1 POUCH

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	07/02/2010

Labeler - Dalian Rongbang Medical Healthy Devices Co (529882730)

Registrant - Dalian Rongbang Medical Healthy Devices Co (529882730)

Name	Address	ID/FEI	Business Operations
Establishment
Dalian Rongbang Medical Healthy Devices Co		529882730	manufacture

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