ANTI-BACTERIAL HAND - alcohol gel
Jets, Sets, & Elephants Beauty Corp.

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.

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ACTIVE INGREDIENT

Ethyl Alcohol 62% w/w

PURPOSE

Anti-bacterial

USE

To decrease bacteria on the skin and clean hands.
Recommended for repeated use.

WARNINGS

For external use only. Flammable, keep away from fire or flame.

Keep out of reach of children.

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

Do not get into eyes.

If contact occurs, rinse thoroughly with water.

Discontinue use

if irritation or redness develop. If irritation persists for more than 72 hours, consult a doctor.

DIRECTIONS

Apply to hands until thoroughly wet.
Rub vigorously until dry.
Supervise children in the use of this product.

Inactive Ingredients

Sweet Cherry Blossom

Water, Propylene Glycol, Parfum, Aloe Barbadensis, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Triethanolamine, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Tocopheryl Acetate, Iron Oxide, Retinyl Palmitate, Red 33, Yellow 5

Warm Vanilla Sugar

Vanilla Bean Noel

Merry Berry

Peppermint Twist

QUESTIONS?

1-800-FDA-1088

Made in China

Distributed by Jets, Sets & Elephants Beauty Corp.

For ShopKo Stores Operating Co., LLC

Green Bay, WI 54307, U.S.A

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

bath-body-etc®

Sweet Cherry Blossom

anti-bacterial

hand gel

PARABEN FREE

contains aloe vera and

vitamins A & E

1 fl oz

Sweet Cherry Blossom Bottle Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

bath-body-etc®

Warm Vanilla Sugar

anti-bacterial

hand gel

PARABEN FREE

contains aloe vera and

vitamins A & E

1 fl oz

Warm Vanilla Sugar Bottle Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

bath-body-etc®

Vanilla Bean Noel

anti-bacterial

hand gel

1 fl oz

Vanilla Bean Noel Bottle Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

bath-body-etc®

Merry Berry

anti-bacterial

hand gel

1 fl oz

Merry Berry Bottle Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

bath-body-etc®

Peppermint Twist

anti-bacterial

hand gel

1 fl oz

Peppermint Twist Bottle Label

ANTI-BACTERIAL HAND
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50988-270
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (ALCOHOL)	ALCOHOL	18.335 mL in 29.574 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
PROPYLENE GLYCOL
ALOE VERA LEAF
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S))
POLYSORBATE 20
TROLAMINE
LACTOSE
.ALPHA.-TOCOPHEROL ACETATE, D-
FERRIC OXIDE RED
VITAMIN A PALMITATE
D&C RED NO. 33
FD&C YELLOW NO. 5

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:50988-270-00	4 CARTON ( CARTON) in 1 BOX	contains a CARTON
1		12 BOTTLE, PLASTIC ( BOTTLE) in 1 CARTON	This package is contained within the BOX (50988-270-00) and contains a BOTTLE, PLASTIC
1		29.574 mL in 1 BOTTLE, PLASTIC	This package is contained within a CARTON and a BOX (50988-270-00)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333A	04/11/2011

ANTI-BACTERIAL HAND
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50988-271
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (ALCOHOL)	ALCOHOL	18.335 mL in 29.574 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
PROPYLENE GLYCOL
ALOE VERA LEAF
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S))
POLYSORBATE 20
TROLAMINE
LACTOSE
.ALPHA.-TOCOPHEROL ACETATE, D-
FERRIC OXIDE RED
VITAMIN A PALMITATE
D&C RED NO. 33
FD&C YELLOW NO. 5
FD&C BLUE NO. 1

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:50988-271-00	4 CARTON ( CARTON) in 1 BOX	contains a CARTON
1		12 BOTTLE, PLASTIC ( BOTTLE) in 1 CARTON	This package is contained within the BOX (50988-271-00) and contains a BOTTLE, PLASTIC
1		29.574 mL in 1 BOTTLE, PLASTIC	This package is contained within a CARTON and a BOX (50988-271-00)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333A	04/11/2011

ANTI-BACTERIAL HAND
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50988-272
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (ALCOHOL)	ALCOHOL	18.335 mL in 29.574 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
PROPYLENE GLYCOL
ALOE VERA LEAF
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S))
POLYSORBATE 20
TROLAMINE
LACTOSE
.ALPHA.-TOCOPHEROL ACETATE, D-
VITAMIN A PALMITATE
ULTRAMARINE BLUE
D&C RED NO. 33
FD&C YELLOW NO. 5
FD&C BLUE NO. 1

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:50988-272-00	4 CARTON ( CARTON) in 1 BOX	contains a CARTON
1		12 BOTTLE, PLASTIC ( BOTTLE) in 1 CARTON	This package is contained within the BOX (50988-272-00) and contains a BOTTLE, PLASTIC
1		29.574 mL in 1 BOTTLE, PLASTIC	This package is contained within a CARTON and a BOX (50988-272-00)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333A	08/10/2011

ANTI-BACTERIAL HAND
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50988-273
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (ALCOHOL)	ALCOHOL	18.335 mL in 29.574 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
PROPYLENE GLYCOL
ALOE VERA LEAF
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S))
POLYSORBATE 20
TROLAMINE
LACTOSE
.ALPHA.-TOCOPHEROL ACETATE, D-
VITAMIN A PALMITATE
ULTRAMARINE BLUE
D&C RED NO. 33
FD&C YELLOW NO. 5
FD&C BLUE NO. 1

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:50988-273-00	4 CARTON ( CARTON) in 1 BOX	contains a CARTON
1		12 BOTTLE, PLASTIC ( BOTTLE) in 1 CARTON	This package is contained within the BOX (50988-273-00) and contains a BOTTLE, PLASTIC
1		29.574 mL in 1 BOTTLE, PLASTIC	This package is contained within a CARTON and a BOX (50988-273-00)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333A	08/10/2011

ANTI-BACTERIAL HAND
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50988-274
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (ALCOHOL)	ALCOHOL	18.335 mL in 29.574 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
PROPYLENE GLYCOL
ALOE VERA LEAF
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S))
POLYSORBATE 20
TROLAMINE
LACTOSE
.ALPHA.-TOCOPHEROL ACETATE, D-
VITAMIN A PALMITATE
ULTRAMARINE BLUE
D&C RED NO. 33
FD&C YELLOW NO. 5
FD&C BLUE NO. 1

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:50988-274-00	4 CARTON ( CARTON) in 1 BOX	contains a CARTON
1		12 BOTTLE, PLASTIC ( BOTTLE) in 1 CARTON	This package is contained within the BOX (50988-274-00) and contains a BOTTLE, PLASTIC
1		29.574 mL in 1 BOTTLE, PLASTIC	This package is contained within a CARTON and a BOX (50988-274-00)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333A	08/10/2011

Labeler - Jets, Sets, & Elephants Beauty Corp. (243254039)

Establishment
Name	Address	ID/FEI	Operations
Gold Orient International Limited		679905914	MANUFACTURE

Revised: 06/2011 Jets, Sets, & Elephants Beauty Corp.