ZYTEC GERM BUSTER HAND SANITIZER- ethanol gel 
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.

----------

Drug Facts for an OTC Hand Sanitizer

Active Ingredient

Ethyl Alcohol 65%

Purpose

Antiseptic

  • For handwashing to decrease bacteria on the skin
  • Recommended for repeat use

Warnings

For external use only

Flammable, keep away from fire or flame.

Do not use in the 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.

  • wet hands thoroughly with product
  • briskly rub hands together until dry
  • supervise children in the use of this product

  • wet hands generously with product,  rub hands together gently until dry.

Other Information

  • store at 20o to 25o  (68o to 77oF)
  • may discolor fabrics

Inactive Ingredients

Aloe barbadensis leaf juice, tocopheryl acetate (vitamin E), isopropyl alcohol,

aminomethyl propanol, carbomer, glycerin, isopropyl myristate, propylene glycol,

methyl gluceth-10, polysorbate 20, fragrance, water.

Product Labels

MM1
label
ZYTEC  GERM BUSTER HAND SANITIZER
ethanol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50021-065
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ETHANOL (UNII: 3K9958V90M) (ETHANOL - UNII:3K9958V90M) ETHANOL143 g  in 238 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50021-065-01238 g in 1 BOTTLE, PUMP
2NDC:50021-065-0252 g in 1 BOTTLE, PLASTIC
3NDC:50021-065-03104 g in 1 BOTTLE, PLASTIC
4NDC:50021-065-04908 g in 1 BOTTLE, PUMP
5NDC:50021-065-05475 g in 1 BOTTLE, PUMP
6NDC:50021-065-06713 g in 1 BOTTLE, PUMP
7NDC:50021-065-07908 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/28/2011
Labeler - Empack (252047519)
Registrant - Empack (252047519)
Establishment
NameAddressID/FEIBusiness Operations
Empack252047519manufacture

Revised: 1/2011
Document Id: da941e21-1a79-11e0-ac64-0800200c9a66
Set id: 3cbad16f-091e-11e0-81e0-0800200c9a66
Version: 4
Effective Time: 20110128
 
Empack