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First Aid Antiseptic by Unishield

Medically reviewed on January 29, 2018

Dosage form: spray
Ingredients: benzalkonium chloride 1mg in 1g, benzocaine 50mg in 1g
Labeler: Unishield
NDC Code: 49314-0098

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
  • 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
  • spray over cleaned affected 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

Questions?

call 1-800-480-5855

Principal Display Panel - Bottle Label

UniShield

FIRST AID
ANTISEPTIC
SPRAY

TREATS:

  • Minor Cuts
  • Scrapes
  • Scratches

HELPS:

  • Prevent Infection
  • Relieve Pain

NET CONTENTS 2 FL. OZ. (59.1 ML)

Distributed by: Unishield, San Francisco, CA 91340

Made in USA

FIRST AID ANTISEPTIC 
benzalkonium chloride and benzocaine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49314-0098
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzalkonium chloride (benzalkonium) benzalkonium chloride1 mg  in 1 g
benzocaine (benzocaine) benzocaine50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
isopropyl alcohol 
water 
Packaging
#Item CodePackage Description
1NDC:49314-0098-159 g in 1 BOTTLE, SPRAY
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/FEIOperations
Safetec of America, Inc 874965262MANUFACTURE(49314-0098)

 
Unishield

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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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