BBL ADVANCED HAND SANITIZER REFRESHING- alcohol gel 
Boston Biolabs. Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

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

Image of bottle

BBL ADVANCED HAND SANITIZER REFRESHING 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78579-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL350 g  in 500 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78579-010-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/01/2020
Labeler - Boston Biolabs. Inc. (695890000)
Registrant - Boston Biolabs. Inc. (695890000)
Establishment
NameAddressID/FEIBusiness Operations
DongbangCosmetics Co., ltd.694452564manufacture(78579-010)

Revised: 6/2020
Document Id: 66a9f952-d5c6-442a-b5c3-28066833a888
Set id: c5a48c1e-e218-4150-a933-e4e96a856007
Version: 1
Effective Time: 20200608
 
Boston Biolabs. Inc.