HAND SANITIZER- alcohol antiseptic gel

Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Alcohol 70% w/w

PURPOSE

Purpose Antiseptic

INDICATIONS & USAGE

Uses Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

WARNINGS

Warnings

For external use only. Flammable. Keep away from heat or flame.

Do not use in children less than 2 months of age on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

DOSAGE & ADMINISTRATION

Directions  Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

OTHER SAFETY INFORMATION

Other information Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT

Inactive ingredients Aminomethyl Propanol, t-Butyl Alcohol, Carbomer, Denatonium Benzoate, Fragrance (Parfum), Glycerin, Water (Aqua)

PRINCIPAL DISPLAY PANEL

Revision Hand Sanitizer Label

Goodier Hand Sanitizer Label

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol antiseptic gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10477-2630
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	73 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.1 mL  in 100 mL
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)	0.09 mL  in 100 mL
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)	0.3 mL  in 100 mL
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)	0.0004 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	3.4 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	18.8 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10477-2630-1	1 in 1 BOTTLE, PLASTIC	06/08/2020
1		1 in 1 NOT APPLICABLE
1		59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/08/2020

Labeler - Goodier Cosmetics (007317209)

Establishment
Name	Address	ID/FEI	Business Operations
Goodier Cosmetics		007317209	manufacture(10477-2630)