OBSTETRICAL ANTISEPTIC- benzalkonium chloride swab

Obstetrical Antiseptic by

Drug Labeling and Warnings

Obstetrical Antiseptic by is a Otc medication manufactured, distributed, or labeled by Wuxi Medical Instrument Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42947-630
Route of Administration	TOPICAL

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

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

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

Labeler - Wuxi Medical Instrument Factory (421292863)

Registrant - Wuxi Medical Instrument Factory (421292863)

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