Obstetrical Antiseptic (Benzalkonium Chloride) Swab [Wuxi Medical Instrument Factory] -

OBSTETRICAL ANTISEPTIC (BENZALKONIUM CHLORIDE) SWAB [WUXI MEDICAL INSTRUMENT FACTORY]
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NDC	42947-630-03
Set ID	4ee8955d-9e82-46fd-88c5-b45196145285
Category	HUMAN OTC DRUG LABEL
Packager	Wuxi Medical Instrument Factory
Generic Name
Product Class
Product Number
Application Number	PART333

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PRINCIPAL DISPLAY PANEL

Item# 83791-510-003 NDC#42947-630-03 Qty.1ea

Obstetrical Antiseptic Towelette

Contains: Benzalkonium Chloride 0.13%

For Single Use Only

Caution: Keep out of reach of children

Manufactured by: Wuxi Medical Instrument Factory

No.86 East street, Zhangjing, Wuxi, Jiangsu 214194 China

Made in China
ACTIVE INGREDIENT

Active ingredient

Benzalkonium Chloride, 0.13% w/w
PURPOSE

Purpose

First Aid Antiseptic
WHEN USING

Use

First aid antiseptic to help prevent infection in minor cuts, scrapes, and burns
WARNINGS

Warnings
For external use only. Do not use
In the eyes or apply over large areas of the body
longer than 1 week unless directed by a doctor.
In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.
STOP USE

Stop use and consult a doctor

if the condition persists or gets worse.
KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right way.
INDICATIONS & USAGE

Directions

* Clean the affected area

* Apply a small amount of this product on the area 1 to 3 times daily

* May be covered with a sterile bandage when dry
INACTIVE INGREDIENT

Inactive ingredients

purified water, sodium bicarbonate
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OBSTETRICAL ANTISEPTIC
benzalkonium chloride swab

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.0013 mL in 1 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42947-630-03	1.4 mL in 1 POUCH

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333	01/01/2009

Labeler - Wuxi Medical Instrument Factory (421292863)

Registrant - Wuxi Medical Instrument Factory (421292863)

Name	Address	ID/FEI	Business Operations
Establishment
Wuxi Medical Instrument Factory		421292863	manufacture

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