Drug Facts

Active ingredient

Alcohol 69% v/v

Purpose

Antiseptic

Use

for hand-washing to decrease bacteria on the skin, only when water is not available

Warnings

For external use only

Flammable, keep away from fire and flames

When using this product

do not get into eyes.
if contact occurs, rinse eyes thoroughly with water

Stop use and ask a doctor if

irritation and redness develop

Keep out of reach of children.

if swallowed, get medical help or contact a Poison Control Center right away

Directions

wet hands thoroughly with product and allow to dry without wiping

Inactive ingredients

Raspberry

Water, Glycerin, Propylene Glycol, Carbomer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, Fragrance, Tocopheryl Acetate, Denatonium Benzoate, Blue 1, Red 33.

Strawberry

Water, Glycerin, Propylene Glycol, Carbomer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, Fragrance, Tocopheryl Acetate, Denatonium Benzoate, Red 33.

Product Packaging

strawberry raspberry

ULTRA DEFENSE SANI SMART 2PK HAND SANITIZER
alcohol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74177-987

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:74177-987-01	1 in 1 KIT; Type 0: Not a Combination Product	11/24/2020

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 BOTTLE, PLASTIC	50 mL
Part 2	1 BOTTLE, PLASTIC	50 mL

Part 1 of 2

ULTRA DEFENSE SANI SMART STRAWBERRY HAND SANITIZER
alcohol gel

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	69 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	11/24/2020

Part 2 of 2

ULTRA DEFENSE SANI SMART RASPBERRY HAND SANITIZER
alcohol gel

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	69 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	11/24/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	11/24/2020

Labeler - K7 Design Group Inc. (080357784)

Ultra Defense Sani Smart 2pk Hand Sanitizer