BT21 HAND SANITIZER- alcohol gel 
BALLON BLANC

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%)

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

Image of bottle

BT21 HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78967-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL42 mL  in 60 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78967-020-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/01/2020
Labeler - BALLON BLANC (089595089)
Registrant - BALLON BLANC (089595089)
Establishment
NameAddressID/FEIBusiness Operations
MYUNG COSMETIC688222692manufacture(78967-020)

Revised: 9/2020
Document Id: 6ed2b8ca-d68a-4af7-b2cf-9bc3d6fc39ab
Set id: c105e108-c9a1-4a1d-bdbd-51101a7dd7a8
Version: 1
Effective Time: 20200922
 
BALLON BLANC