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Antiseptic by Afassco Inc.

Medically reviewed on July 31, 2018

Dosage form: spray
Ingredients: benzalkonium chloride 1mg in 1mL, benzocaine 50mg in 1mL
Labeler: Afassco Inc.
NDC Code: 51532-5300

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.

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
  • may be covered with a sterile bandage
  • children under 2 ask a doctor.

Inactive ingredients

isopropyl alcohol, purified water

PRINCIPAL DISPLAY PANEL – bottle label

First Aid
Antiseptic
Spray

Aids in Preventing Infections

  • Temporary Pain Relief
  • Fights Infection
  • Promotes Healing

#623 2 Fl. Oz. (59 mL)

Mfd. For
Afassco
MINDEN, NV 89423

ANTISEPTIC 
benzalkonium chloride, benzocaine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51532-5300
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzalkonium chloride (benzalkonium) benzalkonium chloride1 mg  in 1 mL
benzocaine (benzocaine) benzocaine50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
isopropyl alcohol 
water 
Packaging
#Item CodePackage Description
1NDC:51532-5300-359 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/09/2012
Labeler - Afassco Inc. (609982723)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIOperations
Safetec of America, Inc.874965262MANUFACTURE(51532-5300)

 
Afassco Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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