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Antiseptic by Afassco Inc.

Medically reviewed on July 25, 2017

Dosage form: liquid
Ingredients: benzalkonium chloride 1.0mg in 1mL, benzocaine 50.0mg in 1mL
Labeler: Afassco Inc.
NDC Code: 51532-5301

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.

Antiseptic Cut Cleaner

Drug Facts

Active Ingredients

Benzalkonium Chloride 0.1%

Benzocaine 5.0%

Purpose

First Aid Antiseptic

Topical Pain Relief

Uses

First aid to help prevent infection and for temporary pain relief in minor cuts, scrapes and burns

Warnings

For external use only.

Flammable keep away from fire or flame.

Do not use
  • near eyes or mucous membranes
  • on deep or puncture wounds, animal bites, or serious burns
  • over large areas of the body
  • more than one week unless directed by a doctor

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

Stop use and ask doctor if condition persists or gets worse

Directions
  • clean affected area and spray 1 to 3 times daily
  • tear open packet, unfold towelette and apply on area 1 to 3 times daily
  • may be covered with a sterile bandage
  • children under 2: ask a doctor.

Inactive ingredients

isopropyl alcohol, purified water

PRINCIPAL DISPLAY PANEL –packet label

Afassco

The First Choice
in First Aid

TRIPLE ACTION
CUT CLEANER
ANTISEPTIC
WIPE

1 premoistened towelette

Manufactured for
Afassco
Minden, NV 89423 800-441-6774

ANTISEPTIC 
benzalkonium chloride, benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51532-5301
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzalkonium chloride (benzalkonium) benzalkonium chloride1.0 mg  in 1 mL
benzocaine (benzocaine) benzocaine50.0 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
isopropyl alcohol 
water 
Packaging
#Item CodePackage Description
1NDC:51532-5301-11.568 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/31/2012
Labeler - Afassco Inc. (609982723)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIOperations
Safetec of America, Inc.874965262MANUFACTURE(51532-5301)

 
Afassco Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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