ANTI-BACTERIAL HAND- ethyl alcohol gel

Anti-bacterial Hand by

Drug Labeling and Warnings

Anti-bacterial Hand by is a Otc medication manufactured, distributed, or labeled by Jets, Sets, & Elephants Beauty Corp., Gold Orient International Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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, Blue 1

Vanilla Bean Noel

Water, Propylene Glycol, Parfum, Aloe Barbadensis, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Triethanolamine, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Tocopheryl Acetate, Retinyl Palmitate, Ultramarine, Red 33, Yellow 5, Blue 1

Merry Berry

Water, Propylene Glycol, Parfum, Aloe Barbadensis, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Triethanolamine, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Tocopheryl Acetate, Retinyl Palmitate, Ultramarine, Red 33, Yellow 5, Blue 1

Peppermint Twist

Water, Propylene Glycol, Parfum, Aloe Barbadensis, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Triethanolamine, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Tocopheryl Acetate, Retinyl Palmitate, Ultramarine, Red 33, Yellow 5, Blue 1

Kiss and Tell

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

Spring Fling

Water, Propylene Glycol, Parfum, Aloe Barbadensis, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Polysorbate 20, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Tocopheryl Acetate, Chromium Hydroxide Green, Retinyl Palmitate, Yellow 5, Blue 1

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

Spring Blossom

Water, Propylene Glycol, Parfum, Aloe Barbadensis, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Triethanolamine, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Tocopheryl Acetate, Ultramarine, Retinyl Palmitate, Yellow 5, Blue 1

QUESTIONS?

1-800-FDA-1088

SPL UNCLASSIFIED SECTION

Made in China

Distributed by Jets, Sets & Elephants Beauty Corp.

For ShopKo Stores Operating Co., LLC

Green Bay, WI 54307, U.S.A

©2010 ShopKo Stores Operating Co., LLC

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

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

bath-body-etc®

Kiss and tell

anti-bacterial

hand gel

1 fl oz

Kiss and tell Bottle Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

bath-body-etc®

Spring fling

anti-bacterial

hand gel

1 fl oz

Spring fling Bottle Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

bath-body-etc®

Sweet cherry blossom

anti-bacterial

hand gel

1 fl oz

Sweet cherry blossom Bottle Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

bath-body-etc®

Spring Blossom

anti-bacterial

hand gel

1 fl oz

Spring Blossom Bottle Label

INGREDIENTS AND APPEARANCE

ANTI-BACTERIAL HAND 
ethyl alcohol gel

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	18.335 mL  in 29.574 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 1G56KV7BUJ)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TROLAMINE (UNII: 9O3K93S3TK)
LACTOSE (UNII: J2B2A4N98G)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
FERRIC OXIDE RED (UNII: 1K09F3G675)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50988-270-00	29.574 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not 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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	18.335 mL  in 29.574 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 1G56KV7BUJ)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TROLAMINE (UNII: 9O3K93S3TK)
LACTOSE (UNII: J2B2A4N98G)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
FERRIC OXIDE RED (UNII: 1K09F3G675)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
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: 50988-271-00	29.574 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not 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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	18.335 mL  in 29.574 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 1G56KV7BUJ)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TROLAMINE (UNII: 9O3K93S3TK)
LACTOSE (UNII: J2B2A4N98G)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ULTRAMARINE BLUE (UNII: I39WR998BI)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
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: 50988-272-00	29.574 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not 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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	18.335 mL  in 29.574 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 1G56KV7BUJ)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TROLAMINE (UNII: 9O3K93S3TK)
LACTOSE (UNII: J2B2A4N98G)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ULTRAMARINE BLUE (UNII: I39WR998BI)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
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: 50988-273-00	29.574 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not 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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	18.335 mL  in 29.574 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 1G56KV7BUJ)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TROLAMINE (UNII: 9O3K93S3TK)
LACTOSE (UNII: J2B2A4N98G)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ULTRAMARINE BLUE (UNII: I39WR998BI)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
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: 50988-274-00	29.574 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/10/2011

ANTI-BACTERIAL HAND 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-275
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	18.335 mL  in 29.574 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 1G56KV7BUJ)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TROLAMINE (UNII: 9O3K93S3TK)
LACTOSE (UNII: J2B2A4N98G)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
FERRIC OXIDE RED (UNII: 1K09F3G675)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50988-275-00	29.574 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/15/2011

ANTI-BACTERIAL HAND 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-276
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	18.335 mL  in 29.574 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 1G56KV7BUJ)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TROLAMINE (UNII: 9O3K93S3TK)
LACTOSE (UNII: J2B2A4N98G)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CHROMIC OXIDE (UNII: X5Z09SU859)
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: 50988-276-00	29.574 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/15/2011

ANTI-BACTERIAL HAND 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-277
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	18.335 mL  in 29.574 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 1G56KV7BUJ)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TROLAMINE (UNII: 9O3K93S3TK)
LACTOSE (UNII: J2B2A4N98G)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
FERRIC OXIDE RED (UNII: 1K09F3G675)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50988-277-00	29.574 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/15/2011

ANTI-BACTERIAL HAND 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50988-278
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	18.335 mL  in 29.574 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 1G56KV7BUJ)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TROLAMINE (UNII: 9O3K93S3TK)
LACTOSE (UNII: J2B2A4N98G)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
ULTRAMARINE BLUE (UNII: I39WR998BI)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
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: 50988-278-00	29.574 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/15/2011

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

Establishment
Name	Address	ID/FEI	Business Operations
Gold Orient International Limited		679905914	MANUFACTURE(50988-270, 50988-271, 50988-272, 50988-273, 50988-274, 50988-275, 50988-276, 50988-277, 50988-278)