BURGER TIME HAND SANITIZER- alcohol liquid FRESH FRIES HAND SANITIZER- alcohol liquid PIZZA PARTY HAND SANITIZER- alcohol liquid SPARKLED DONUT HAND SANITIZER- alcohol 62% liquid

Sparkled Donut by

Drug Labeling and Warnings

Sparkled Donut by is a Otc medication manufactured, distributed, or labeled by GL 360. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Ethyl Alcohol  62%

Purpose

Antimicrobial

INDICATIONS & USAGE

Use hand sanitizer to help reduce bacteria on skin.

Warning

Flammable Keep away from heat and flame

WHEN USING

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

STOP USE

Stop use and ask doctor if irritation or redness develops

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

■ Wet hands thoroughly with product and rub into skin until dry.
■ Children Directions
■ Wet hands thoroughly with product and rub into skin until dry.
■ Children under 6 years of age should be supervised by an
adult when using.

INACTIVE INGREDIENT

Inactive
Ingredients
Water (Aqua), Aloe Barbadensis Leaf Juice, Carbomer, Fragrance,
Glycerin, Propylene Glycol, Triethanolamine, Tocopheryl Acetate
FD&C Yellow No. 5, FD&C Blue No. 1

Product Labels for: Burger Time  Fresh Fries  Pizza Party  Sparkled Donut

Burger Time Hand Sanitizer Label

Burger Time

HAND SANITIZER

Drug Facts

Active
Ingredients
Ethyl Alcohol 62.0%

Purpose
Antimicrobial

Use hand sanitizer
to help reduce
bacteria on skin.

ADDITIONAL DRUG FACTS

Distributed By:
Personal Care Products, LLC
Troy, Michigan 48084
Made in China

Drug Facts
(continued)

Flammable Keep
away from heat and
flame

When using this
product avoid contact
with eyes. If contact
occurs, rinse
thoroughly with water.

Stop use and ask
doctor if irritation or
redness develops

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

Drug Facts
(continued)

Directions
■ Wet hands
thoroughly with
product and rub
into skin until dry.
■ Children under
6 years of age
should be
supervised by an
adult when using.

Inactive
Ingredients
Water (Aqua), Aloe
Barbadensis Leaf Juice,
Carbomer, Fragrance,
Glycerin, Propylene
Glycol, Triethanolamine,
Tocopheryl Acetate
FD&C Yellow No. 5,
FD&C Blue No. 1

Fresh Fries Hand Sanitizer Label

Pizza Party Hand Sanitizer Label

Sparkled Donut Hand Sanitizer Label

INGREDIENTS AND APPEARANCE

BURGER TIME  HAND SANITIZER
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29500-9413
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	17.57 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29500-9413-1	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/01/2018

FRESH FRIES  HAND SANITIZER
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29500-9414
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	17.57 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29500-9414-1	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/01/2018

PIZZA PARTY  HAND SANITIZER
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29500-9415
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	17.57 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29500-9415-1	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/01/2018

SPARKLED DONUT  HAND SANITIZER
alcohol 62% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29500-9416
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	17.57 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29500-9416-1	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/01/2018

Labeler - GL 360 (966155082)

Registrant - GL 360 (966155082)