WHITESTONE DOME LIFE HAND SANITIZER- alcohol gel

Whitestone Dome Life Hand Sanitizer by

Drug Labeling and Warnings

Whitestone Dome Life Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by White Stone, Ltd., JUHWANBIO. CELL CO.,LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Alcohol 74.18% v/v

Purpose

Antiseptic

Uses

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

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.

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.

Inactive ingredients

Water, Glycerin, Carbomer, Triethanolamine, Dipropylene Glycol, Tocopheryl Acetate, Hyaluronic acid

Whitestone dome life hand sanitizer

INGREDIENTS AND APPEARANCE

WHITESTONE DOME LIFE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76941-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	74.18 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
HYALURONIC ACID (UNII: S270N0TRQY)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76941-101-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/28/2020

WHITESTONE DOME LIFE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76941-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	74.18 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
HYALURONIC ACID (UNII: S270N0TRQY)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76941-100-01	100 mL in 1 TUBE; Type 0: Not a Combination Product	04/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/28/2020

Labeler - White Stone, Ltd. (690342449)

Establishment
Name	Address	ID/FEI	Business Operations
JUHWANBIO. CELL CO.,LTD.		690163444	manufacture(76941-100, 76941-101)