ZYTEC GERM BUSTER HAND SANITIZER- ethanol gel

Drug Labeling and Warnings

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ZYTEC  GERM BUSTER HAND SANITIZER
ethanol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50021-065
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ETHANOL (UNII: 3K9958V90M) (ETHANOL - UNII:3K9958V90M)	ETHANOL	143 g  in 238 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50021-065-01	238 g in 1 BOTTLE, PUMP
2	NDC: 50021-065-02	52 g in 1 BOTTLE, PLASTIC
3	NDC: 50021-065-03	104 g in 1 BOTTLE, PLASTIC
4	NDC: 50021-065-04	908 g in 1 BOTTLE, PUMP
5	NDC: 50021-065-05	475 g in 1 BOTTLE, PUMP
6	NDC: 50021-065-06	713 g in 1 BOTTLE, PUMP
7	NDC: 50021-065-07	908 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/28/2011

Labeler - Empack (252047519)

Registrant - Empack (252047519)

Establishment
Name	Address	ID/FEI	Business Operations
Empack		252047519	manufacture