ANTIBACTERIAL HAND SANITIZER- ethyl alcohol gel

Antibacterial Hand Sanitizer by

Drug Labeling and Warnings

Antibacterial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Tonic Bath and Body Products Shenzhen Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

ETHYL ALCOHOL 65%

Uses

For handwashing to decrease bacteria on the skin.

Warnings

For external use only.

When using this product

Avoid contact with eyes. If contact occurs flush eyes with water.

Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

Keep out of the reach of children

If swallowed get medical help or contact a Poison Control Center right away.

Directions

Wet hands thoroughly with product and allow to dry without wiping. Repeat as necessary. Supervise children with use of this product.

Inactive Ingredients

Aminomethyl Propanol, Benzophenone-3, Carbomer, Deinized Aqua (water), Glycerin, Isopropyl Palmitate, Polyaminopropyl Biguanide, Propylene Glycol, Tocopheryll Acetate (Vitamin E).

HOW SUPPLIED

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43333-451
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
OXYBENZONE (UNII: 95OOS7VE0Y)
CARBOMER 940 (UNII: 4Q93RCW27E)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43333-451-06	236 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/16/2015

Labeler - Tonic Bath and Body Products Shenzhen Ltd. (528197042)

Establishment
Name	Address	ID/FEI	Business Operations
Tonic Bath and Body Products Shenzhen Ltd.		528197042	manufacture(43333-451)