ANTISEPTIC- benzalkonium chloride, benzocaine spray 
Afassco 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.

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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

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

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

Bottle label

res

ANTISEPTIC 
benzalkonium chloride, benzocaine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51532-5300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y) benzalkonium chloride1 mg  in 1 mL
benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5) benzocaine50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
isopropyl alcohol (UNII: ND2M416302)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51532-5300-359 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/09/2012
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/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(51532-5300)

Revised: 1/2023
Document Id: f5940692-ef5c-492d-9d0b-c8c477eebb50
Set id: 3eb119d8-59da-405c-a5f4-a025636d394a
Version: 4
Effective Time: 20230112
 
Afassco Inc.