ZYTEC GERM BUSTER HAND SANITIZER- ethanol aerosol, spray 
Empack

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 for an OTC Aerosol Hand Sanitizer

Active Ingredients

Ethyl Alcohol 80%

Purpose

Antiseptic

Uses

  • For handwashing to decrease bacteria on the skin
  • recommended for repeated use

Warnings

For external use only

Flammable, keep away from fire or flame.

Contents under pressure

Do not puncture of incinerate

Do not expose to heat or store at temperatures above 120oF / 50oC or in enclosed places that could overheat.

Do not use in or near eyes.  In case of contact rinse eyes thoroughly with water.

Stop use and ask a doctor if, irritation and redness develop and persists for more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • spray in palm of hand ans rub over entire surface of hands
  • briskly rub hands together until dry
  • supervise children in the use of this product

  • spray product generously over hands, rub together until product drys.

Other Information

  • may discolor certain fabric

Inactive Ingredients

Water (aqua) , Isobutene, Fragrance,

MM2
product label
ZYTEC  GERM BUSTER HAND SANITIZER
ethanol aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50021-080
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ETHANOL (UNII: 3K9958V90M) (ETHANOL - UNII:3K9958V90M) ETHANOL224 g  in 400 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50021-080-0835 g in 1 CAN
2NDC:50021-080-09400 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/31/2011
Labeler - Empack (252047519)
Registrant - Empack (252047519)
Establishment
NameAddressID/FEIBusiness Operations
Empack252047519manufacture

Revised: 1/2011
Document Id: da941e20-1a79-11e0-ac64-0800200c9a66
Set id: 283cdcc1-0c4c-11e0-81e0-0800200c9a66
Version: 5
Effective Time: 20110131
 
Empack