BT21 HAND SANITIZER- alcohol gel

BT21 HAND SANITIZER by

Drug Labeling and Warnings

BT21 HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by BALLON BLANC, MYUNG COSMETIC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Alcohol (70%)

INACTIVE INGREDIENTS

Water, Triethanolamine, Glycerin, Carbomer, Polysorbate 20, Tocopheryl Acetate, Perfume

PURPOSE

Antiseptic

WARNINGS

For external use only
Do not use if you are allergic to any of the ingredients
When using this product Avoid contact with eyes. in case of contact, rinse eyes thoroughly with water. Avoid contact with broken, irritate. or itching skin.
Stop use and ask a doctor if irritation or redness develops and condition persists for more than 72 hours.
Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center(1-800-222-1222) right away.
If pregnant or brest-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center(1-800-222-1222) right away.

Uses

Hand sanitizer for decreasing bacteria on skin

Directions

Apply the appropriate amount of the product onto your hands and spread it thoroughly.

Rub hands together until it dries.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BT21 HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78967-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	42 mL  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
Glycerin (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
Polysorbate 20 (UNII: 7T1F30V5YH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78967-020-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/01/2020

Labeler - BALLON BLANC (089595089)

Registrant - BALLON BLANC (089595089)

Establishment
Name	Address	ID/FEI	Business Operations
MYUNG COSMETIC		688222692	manufacture(78967-020)