HAND SANITIZER- ethyl alcohol gel 
Atara Holdings 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
Ethyl Alcohol 62%

Purpose
Antiseptic

Warnings

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

Stop use and ask a doctor if irritation or rash appears and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a doctor right away.

Directions

Pump as needed into your palms to cover hands. Rub hands together briskly unitl dry. Children under 6 years old should be supervised when using this product.

Inactive Ingredients

Water, Aloe Barbadensis Leaf Juice, Fragrance, Glycerin, Propylene Glycol, Carbomer, Aminomethyl Propanol, Lactose, Microcrystalline Cellulose, Sucrose, Zea Mays (corn) Starch, Ultramarine Blue CI 77007, Tocopheryl Acetate, Hydroxpropyl Methyl Cellulose, D&C Red No.33, FD&C Blue No.1.

Uses

To help reduce bacteria on the skin.

image of bottle label

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71154-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
LACTOSE (UNII: J2B2A4N98G)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SUCROSE (UNII: C151H8M554)  
STARCH, CORN (UNII: O8232NY3SJ)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71154-001-0129 mL in 1 BOTTLE; Type 0: Not a Combination Product12/24/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E12/24/2016
Labeler - Atara Holdings Inc (080473576)

Revised: 12/2016
Document Id: 44689ee0-5222-0689-e054-00144ff88e88
Set id: 44689ee0-5221-0689-e054-00144ff88e88
Version: 1
Effective Time: 20161224
 
Atara Holdings Inc