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Package Insert and Label Information: Antiseptic Towelettes

By Medline Industries, Inc. | Last revised: 31 August 2008

ANTISEPTIC TOWELETTES- benzalkonium chloride cloth
Medline Industries, Inc.

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.

Active ingredient

Benzalkonium Chloride

Purpose

First Aid Antiseptic

Use

As a First Aid Antiseptic to help prevent infection in minor cuts, scrapes and burns

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

Stop use and ask a doctor if

  • condition persists or gets worse
  • you have deep or puncture wounds, animal bites or serious burns

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

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
  • If bandaged, let dry first

Storage

Store at room temperature: 20 to 25 degrees C (68 to 77 degrees F)

Inactive ingredients

Isopropyl Alcohol, Fragrance, Propylene Glycol, Sodium Bicarbonate, Water

Questions

1-800-MEDLINE

Principal Display Panel

Antiseptic Towelettes

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ANTISEPTIC TOWELETTES
benzalkonium chloride cloth
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-929
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzalkonium Chloride (Benzalkonium) Benzalkonium Chloride 0.0013 mL
Inactive Ingredients
Ingredient Name Strength
Isopropyl Alcohol
Propylene Glycol
Sodium Bicarbonate
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53329-929-09 100 CLOTH (SWAB) in 1 CANISTER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333 01/01/2007
Labeler — Medline Industries, Inc. (025460908)

Revised: 08/2008 Medline Industries, Inc.