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Name:Antiseptic Towelette
Manufacturer:Genuine First Aid Llc
Category:Over-the-counter (OTC) Marketed Drugs


Antiseptic Towelette

ANTISEPTIC TOWELETTE   - benzalkonium chloride swab 
Genuine First Aid LLC

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.

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Antiseptic Towelette

Active Ingredient

Active Ingredient:                        

Benzalkonium Chloride 0.40%

Purpose


Antiseptic

Use

For Professional and Hospital use.  Helps prevent infection.  Antiseptic cleansing of face, hands and body without soap and water.

Warnings

Warning:   For external use only.

Keep out of reach of children:  If swallowed, get medical help or contact a Poison Control Center right away.

Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.

Do not use in the eyes or over large areas of the body.

Directions

Tear open packet, unfold towelette and use to cleanse desired skin area.  Discard towelette appropriately after single use.


Inactive Ingredients

Inactive Ingredient:   Purified water


LOT/EXP:                           Made in CHINA

20130301

Antiseptic Towelette

Genuine First Aid LLC, Clearwater FL 33755

www.GenuineFirstAid.com

1/pouch

GENUINE FIRST AID

AntisepticTowelette

Antiseptic Towelette

Antiseptic Towelette


ANTISEPTIC TOWELETTE  
benzalkonium chloride swab
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52124-0001
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.40 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52124-0001-1 0.8 mL in 1 PACKAGE None
2 NDC:52124-0001-2 10 PACKET ( PACKET) in 1 BOX contains a PACKET
2 0.8 mL in 1 PACKET This package is contained within the BOX (52124-0001-2)
3 NDC:52124-0001-3 100 PACKET ( PACKET) in 1 BOX contains a PACKET
3 0.8 mL in 1 PACKET This package is contained within the BOX (52124-0001-3)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 04/23/2010

Labeler - Genuine First Aid LLC (619609857)

Revised: 02/2011 Genuine First Aid LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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