BBL ADVANCED HAND SANITIZER REFRESHING- alcohol gel

BBL Advanced Hand Sanitizer Refreshing by

Drug Labeling and Warnings

BBL Advanced Hand Sanitizer Refreshing by is a Otc medication manufactured, distributed, or labeled by Boston Biolabs. Inc., DongbangCosmetics Co., ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ALCOHOL 70% w/w

INACTIVE INGREDIENTS

Water, Carbomer, Triethanolamine, Lavandula Angustifolia (Lavender) Oil, Butylene Glycol, Hexylene Glycol, Fragaria Chiloensis (Strawberry) Fruit Extract, Camellia Sinensis Leaf Extract

PURPOSE

Antiseptic

WARNINGS

For external use only. Flammable. Keep away from fire 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.

Uses

Hand sanitizer to help reduce bacteria on the skin that could cause disease.

Recommended for repeated use.

Directions

Put enough product in your palm to cover hands and rub hands together briskly until dry.
Children under 6 years of age should be supervised when using this product.

Other information

Store below 110°F (43°C).
May discolor certain fabrics or surfaces.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BBL ADVANCED HAND SANITIZER REFRESHING 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78579-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	350 g  in 500 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
LAVENDER OIL (UNII: ZBP1YXW0H8)
Butylene Glycol (UNII: 3XUS85K0RA)
Hexylene Glycol (UNII: KEH0A3F75J)
BEACH STRAWBERRY (UNII: 98542F2TQS)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78579-010-01	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/01/2020

Labeler - Boston Biolabs. Inc. (695890000)

Registrant - Boston Biolabs. Inc. (695890000)

Establishment
Name	Address	ID/FEI	Business Operations
DongbangCosmetics Co., ltd.		694452564	manufacture(78579-010)