ULTRA DEFENSE SANI SMART MOISTURIZING AND SANITIZER- alcohol kit

Ultra Defense Sani Smart Moisturizing and Sanitizer by

Drug Labeling and Warnings

Ultra Defense Sani Smart Moisturizing and Sanitizer by is a Otc medication manufactured, distributed, or labeled by K7 Design Group Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Alcohol 69% v/v

Purpose

Antiseptic

Uses

• to decrease bacteria on the skin that could cause disease
• recommended for repeated use

Warnings

For external use only

Flammable, keep away from fire or flame.

When using this product

• keep out of eyes. In case of contact with eyes, flush thoroughly with water
• avoid contact with broken skin
• do not inhale or ingest

Stop use and ask a doctor if

• irritation and redness develop and persist for more than 72 hours

Keep out of reach of children.

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

Directions

• Spray directly on hands and rub in thoroughly
• For children under 6, use adult supervision
• Not recommended for infants

Other information

• Store between 15-30 C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Water, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Fragrance, Denatonium Benzoate.

Company Information

MANUFACTURED FOR & DISTRIBUTED BY K7 DESIGN GROUP LLC. 2433 KNAPP STREET, BROOKLYN, NY 11235

ORIGIN: CHINA

Product Packaging

INGREDIENTS AND APPEARANCE

ULTRA DEFENSE SANI SMART MOISTURIZING AND SANITIZER 
alcohol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74177-955

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74177-955-01	1 in 1 KIT; Type 0: Not a Combination Product	10/14/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, SPRAY	100 mL
Part 2	1 BOTTLE, PLASTIC	73 mL

Part 1 of 2

ULTRA DEFENSE SANI SMART HAND SANITIZER 
alcohol spray

Product Information
Item Code (Source)	NDC: 74177-954
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74177-954-01	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/14/2020

Part 2 of 2

ULTRA DEFENSE SANI SMART MOISTURIZING HAND 
lotions, oils, powders, and creams lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	PEG-100 STEARATE (UNII: YD01N1999R)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
INGR	ETHYLHEXYL PALMITATE (UNII: 2865993309)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
INGR	WATER (UNII: 059QF0KO0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		73 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/14/2020

Labeler - K7 Design Group Inc. (080357784)