Drug Labeling and Warnings

Drug Details [pdf]

ANTISEPTIC- benzalkonium chloride spray 
Unifirst First Aid Corporation

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 0.13%

Purpose

First aid antiseptic

Uses

First aid to help prevent infection in minor cuts, scrapes and burns

Warnings

For external use only.

Do not use

  • near eyes or mucous membranes
  • on deep or puncture wounds, animal bites, or serious burns consult a doctor

Keep out of reach of children.

Caution

  • not for use on large areas of the body
  • if redness, irritation, swelling or pain persists or increases, discontinue use and consult a physician

Directions

  • spray over affected area
  • if bandaged, let dry first
  • not to be used on children under 12 years of age

Inactive ingredient

alcohol, purified water

Questions or comments?

1-800-869-6970

Principal Display Panel - Bottle Label

NDC: 47682-306-02

Antiseptic
spray

Topical Antiseptic

  • fast and easy way to disinfect minor
    cuts, scratches and abrasions

GREEN GUARD®

2 Fl. Oz. (59.1 ML)

Principal Display Panel - Bottle Label
ANTISEPTIC 
benzalkonium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 47682-306
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 g  in 1 L
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 47682-306-020.0591 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/10/201505/16/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/10/201505/16/2019
Labeler - Unifirst First Aid Corporation (832947092)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262manufacture(47682-306)

Revised: 11/2017
Document Id: 5d51dab1-2857-e33b-e053-2a91aa0ac7ff
Set id: 4e2a0c1f-59a8-406e-9d1f-3bd400dde914
Version: 3
Effective Time: 20171106