FIRST AID ANTISEPTIC- benzalkonium chloride and benzocaine spray 
Unishield

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

  • near eyes or mucous membranes
  • on deep or puncture wounds, animal bites, or
  • 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 a doctor if condition persists or gets worse

Directions

Inactive ingredients

isopropyl alcohol, purified water

Questions?

call 1-800-480-5855

Principal Display Panel - Bottle Label

UniShield

FIRST AID
ANTISEPTIC
SPRAY

TREATS:

HELPS:

NET CONTENTS 2 FL. OZ. (59.1 ML)

Distributed by: Unishield, San Francisco, CA 91340

Made in USA

Principal Display Panel-Bottle Label
FIRST AID ANTISEPTIC 
benzalkonium chloride and benzocaine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49314-0098
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y) benzalkonium chloride1 mg  in 1 g
benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5) benzocaine50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
isopropyl alcohol (UNII: ND2M416302)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49314-0098-159 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/27/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/27/2015
Labeler - Unishield (790677053)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc 874965262MANUFACTURE(49314-0098)

Revised: 1/2015
Document Id: d1fe3a50-474a-4247-a525-a383b67fe3c0
Set id: e415a3c8-5ca3-4593-b0a6-0c12d3e0ccfa
Version: 2
Effective Time: 20150127
 
Unishield