FDA Label for Obstetrical Antiseptic

View Indications, Usage & Precautions

Obstetrical Antiseptic Product Label

The following document was submitted to the FDA by the labeler of this product Wuxi Medical Instrument Factory. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Package Label.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


Otc - Active Ingredient



Active ingredient

Benzalkonium Chloride, 0.13% w/w


Otc - Purpose



Purpose

First Aid Antiseptic


Otc - When Using



Use

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


Warnings



WarningsFor external use only. Do not useIn the eyes or apply over large areas of the bodylonger than 1 week unless directed by a doctor.In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

Otc - Stop Use



Stop use and consult a doctor

if the condition persists or gets worse.


Otc - 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


* Please review the disclaimer below.