CHEMISPHERE HAND SANITIZER- hand sanitizer gel

Chemisphere Hand Sanitizer by

Drug Labeling and Warnings

Chemisphere Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Chemisphere Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethyl Alcohol 63%

PURPOSE

Antimicrobial

Directions

Wet hands with enough product to cover hands. Rub hands together and allow to dry.

Children under 6 require adult supervision.

Warnings

For external use only.

Flammable. Keep away from heat and flame.

When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

Stop use and ask a doctor is irritation or rash develops.

INACTIVE INGREDIENT

Water, Glycerin, Tocopheryl Acetate, T-Butyl Alcohol, Carbomer, Fragrance

INDICATIONS & USAGE

Hand sanitizer to decrease bacterial on the skin.

KEEP OUT OF REACH OF CHILDREN

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CHEMISPHERE HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61034-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	63 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYLAMINE (UNII: BR9JLI40NO)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61034-001-02	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2016

Labeler - Chemisphere Corp (071957146)

Establishment
Name	Address	ID/FEI	Business Operations
Chemisphere Corp		071957146	manufacture(61034-001)