SHOPKO ANTIBACTERIAL DEEP CLEANSING HAND- triclosan 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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bath+body+etc® antibacterial deep cleansing hand soap - Ocean Breeze, Cherry Blossom, Warm Vanilla Sugar, Dark Raspberry, and Red Pomegranate

Active ingredient

Triclosan 0.2%

Purpose

Antibacterial

Uses

Warnings

For external use only.

When using this product

Avoid contact with eyes. If contact occurs, rinse 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

Inactive Ingredients

Ocean Breeze

Acrylates copolymer, Aloe Barbadensis Leaf Juice, Benzophenone-4, Blue 1, Cellulose, Cocamide DEA, Cocamidopropyl Betaine, Disodium EDTA, DMDM Hydantoin, Hydroxypropyl methylcellulose, Lactose, Methylchloroisothiazolinone, Methylisothiazolinone, Parfum, PEG-150 Distearate, Polysorbate 20, Retinyl Palmitate, Red 33, Silica, Sodium Chloride, Sodium Hydroxide, Sodium Laureth Sulfate, Tocopheryl Acetate, Ultramarines, Water (Aqua).

Cherry Blossom

Acrylates copolymer, Aloe Barbadensis Leaf Juice, Benzophenone-4, Cellulose, Cocamide DEA, Cocamidopropyl Betaine, Disodium EDTA, DMDM Hydantoin, Hydroxypropyl methylcellulose, Lactose, Methylchloroisothiazolinone, Methylisothiazolinone, Parfum, PEG-150 Distearate, Polysorbate 20, Red 33, Retinyl Palmitate, Silica, Sodium Chloride, Sodium Hydroxide, Sodium Laureth Sulfate, Tocopheryl Acetate, Ultramarines, Water (Aqua), Yellow 5.

Warm Vanilla Sugar

Acrylates copolymer, Aloe Barbadensis Leaf Juice, Benzophenone-4, Cellulose, Cocamide DEA, Cocamidopropyl Betaine, Disodium EDTA, DMDM Hydantoin, Hydroxypropyl methylcellulose, Lactose, Methylchloroisothiazolinone, Methylisothiazolinone, Parfum, PEG-150 Distearate, Polysorbate 20, Red 33, Retinyl Palmitate, Silica, Sodium Chloride, Sodium Hydroxide, Sodium Laureth Sulfate, Tocopheryl Acetate, Ultramarines, Water (Aqua), Yellow 5.

Dark Raspberry

Acrylates copolymer, Aloe Barbadensis Leaf Juice, Benzophenone-4, Blue 1, Cellulose, Cocamide DEA, Cocamidopropyl Betaine, Disodium EDTA, DMDM Hydantoin, Hydroxypropyl methylcellulose, Lactose, Methylchloroisothiazolinone, Methylisothiazolinone, Parfum, PEG-150 Distearate, Polysorbate 20, Red 33, Retinyl Palmitate, Silica, Sodium Chloride, Sodium Hydroxide, Sodium Laureth Sulfate, Tocopheryl Acetate, Ultramarines, Water (Aqua), Yellow 5.

Red Pomegranate

Acrylates copolymer, Aloe Barbadensis Leaf Juice, Benzophenone-4, Cellulose, Cocamide DEA, Cocamidopropyl Betaine, Disodium EDTA, DMDM Hydantoin, Hydroxypropyl methylcellulose, Lactose, Methylchloroisothiazolinone, Methylisothiazolinone, Parfum, PEG-150 Distearate, Polysorbate 20, Red 33, Retinyl Palmitate, Silica, Sodium Chloride, Sodium Hydroxide, Sodium Laureth Sulfate, Tocopheryl Acetate, Ultramarines, Water (Aqua), Yellow 5.

Questions?

1-800-FDA-1088

Package/Label Principal Display Panel - Bottle Label

bath+body+etc®

Ocean Breeze

antibacterial

deep cleansing

hand soap

10.1 fl oz

Made in China

Distributed by Jets, Sets & Elephants Beauty Corp.

For Shopko Stores Operating Co., LLC

Green Bay, WI 54307, U.S.A.

©2012 Shopko Stores Operating Co., LLC

Principal Display Panel - Ocean Breeze

Ocean Breeze Bottle Label

Package/Label Principal Display Panel - Bottle Label

bath+body+etc®

Cherry Blossom

antibacterial

deep cleansing

hand soap

10.1 fl oz

Made in China

Distributed by Jets, Sets & Elephants Beauty Corp.

For Shopko Stores Operating Co., LLC

Green Bay, WI 54307, U.S.A.

©2012 Shopko Stores Operating Co., LLC

Principal Display Panel - Cherry Blossom

Cherry Blossom Bottle Label

Package/Label Principal Display Panel - Bottle Label

bath+body+etc®

Warm Vanilla Sugar

antibacterial

deep cleansing

hand soap

10.1 fl oz

Made in China

Distributed by Jets, Sets & Elephants Beauty Corp.

For Shopko Stores Operating Co., LLC

Green Bay, WI 54307, U.S.A.

©2012 Shopko Stores Operating Co., LLC

Principal Display Panel - Warm Vanilla Sugar

Warm Vanilla Sugar Bottle Label

Package/Label Principal Display Panel - Bottle Label

bath+body+etc®

Dark Raspberry

antibacterial

deep cleansing

hand soap

10.1 fl oz

Made in China

Distributed by Jets, Sets & Elephants Beauty Corp.

For Shopko Stores Operating Co., LLC

Green Bay, WI 54307, U.S.A.

©2012 Shopko Stores Operating Co., LLC

Principal Display Panel - Dark Raspberry

Dark Raspberry Bottle Label

Package/Label Principal Display Panel - Bottle Label

bath+body+etc®

Red Pomegranate

antibacterial

deep cleansing

hand soap

10.1 fl oz

Made in China

Distributed by Jets, Sets & Elephants Beauty Corp.

For Shopko Stores Operating Co., LLC

Green Bay, WI 54307, U.S.A.

©2012 Shopko Stores Operating Co., LLC

Principal Display Panel - Red Pomegranate

Red Pomegranate Bottle Label

SHOPKO ANTIBACTERIAL DEEP CLEANSING HAND 
triclosan gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50988-450
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
LACTOSE (UNII: J2B2A4N98G)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
SULISOBENZONE (UNII: 1W6L629B4K)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50988-450-00299 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/22/2012
SHOPKO ANTIBACTERIAL DEEP CLEANSING HAND 
triclosan gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50988-451
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
LACTOSE (UNII: J2B2A4N98G)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
SULISOBENZONE (UNII: 1W6L629B4K)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50988-451-00299 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/22/2012
SHOPKO ANTIBACTERIAL DEEP CLEANSING HAND 
triclosan gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50988-452
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
LACTOSE (UNII: J2B2A4N98G)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
SULISOBENZONE (UNII: 1W6L629B4K)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50988-452-00299 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/22/2012
SHOPKO ANTIBACTERIAL DEEP CLEANSING HAND 
triclosan gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50988-453
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
LACTOSE (UNII: J2B2A4N98G)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
SULISOBENZONE (UNII: 1W6L629B4K)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50988-453-00299 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/22/2012
SHOPKO ANTIBACTERIAL DEEP CLEANSING HAND 
triclosan gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50988-454
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
LACTOSE (UNII: J2B2A4N98G)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
SULISOBENZONE (UNII: 1W6L629B4K)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50988-454-00299 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/22/2012
Labeler - Jets, Sets, & Elephants Beauty Corp. (243254039)
Establishment
NameAddressID/FEIBusiness Operations
Gold Orient International Limited679905914MANUFACTURE(50988-450, 50988-451, 50988-452, 50988-453, 50988-454)

Revised: 6/2012
Document Id: da428ddd-de07-4b5d-ab9b-1de508ba7957
Set id: da428ddd-de07-4b5d-ab9b-1de508ba7957
Version: 1
Effective Time: 20120628
 
Jets, Sets, & Elephants Beauty Corp.