DailyMed - SHOPKO ANTIBACTERIAL FOAMING HAND SANITIZER- triclosan gel

Contains inactivated NDC Code(s)
NDC Code(s): 50988-296-00, 50988-297-00, 50988-298-00, 50988-299-00, view more
50988-300-00, 50988-301-00, 50988-302-00
Packager: Jets, Sets, & Elephants Beauty Corp.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated August 7, 2012

If you are a consumer or patient please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

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Active ingredient

Triclosan 0.3%
Purpose

Antibacterial
Use
- handwashing to decrease bacteria on skin
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
- wet hands, work into rich lather
- rinse well
Inactive ingredients (Cherry Blossom)

Aloe Barbadensis Leaf Juice, Benzophenone-4, Cocamide DEA, Cocamidopropyl Betaine, Citric Acid, Disodium EDTA, DMDM Hydantoin, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance (Parfum), Propylene Glycol, Red 33, Retinyl Palmitate, Sodium Laureth Sulfate, Tocopheryl Acetate, Water (Aqua), Yellow 5.
Inactive ingredients (Ocean Breeze)

Aloe Barbadensis Leaf Juice, Benzophenone-4, Blue 1, Cocamide DEA, Cocamidopropyl Betaine, Citric Acid, Disodium EDTA, DMDM Hydantoin, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance (Parfum), Propylene Glycol, Red 33, Retinyl Palmitate, Sodium Laureth Sulfate, Tocopheryl Acetate, Water (Aqua).
Inactive ingredients (Warm Vanilla Sugar)

Aloe Barbadensis Leaf Juice, Benzophenone-4, Cocamide DEA, Cocamidopropyl Betaine, Citric Acid, Disodium EDTA, DMDM Hydantoin, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance (Parfum), Propylene Glycol, Red 33, Retinyl Palmitate, Sodium Laureth Sulfate, Tocopheryl Acetate, Water (Aqua), Yellow 5.
Inactive ingredients (Dark Raspberry)

Aloe Barbadensis Leaf Juice, Benzophenone-4, Blue 1, Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, Disodium EDTA, DMDM Hydantoin, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance (Parfum), Propylene Glycol, Red 33, Retinyl Palmitate, Sodium Laureth Sulfate, Tocopheryl Acetate, Water (Aqua), Yellow 5.
Inactive ingredients (Red Pomegranate)

Aloe Barbadensis Leaf Juice, Benzophenone-4, Blue 1,Cocamide DEA, Cocamidopropyl Betaine, Citric Acid, Disodium EDTA, DMDM Hydantoin, Methylchloroisothiazolinone, Methylisothiazolinone, Parfum, Propylene Glycol, Red 33, Retinyl Palmitate, Sodium Laureth Sulfate, Tocopheryl Acetate, Water (Aqua), Yellow 5.
Inactive ingredients (Autumn Orange)

Aloe Barbadensis Leaf Juice, Benzophenone-4, Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, Disodium EDTA, DMDM Hydantoin, Fragrance (Parfum), Methylchloroisothiazolinone, Methylisothiazolinone, Propylene Glycol, Red 33, Retinyl Palmitate, Sodium Laureth Sulfate, Tocopheryl Acetate, Water (Aqua), Yellow 5.
Inactive ingredients (Enchanted Woods)

Aloe Barbadensis Leaf Juice, Benzophenone-4, Blue 1, Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, Disodium EDTA, DMDM Hydantoin, Fragrance (Parfum), Methylchloroisothiazolinone, Methylisothiazolinone, Propylene Glycol, Red 33, Retinyl Palmitate, Sodium Laureth Sulfate, Tocopheryl Acetate, Water (Aqua).
QUESTIONS?

1-800-FDA-1088
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

bath·body·etc®

CHERRY BLOSSOM

anti-bacterial foaming 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

SATISFACTION GUARANTEED BY REFUND OR EXCHANGE

Bottle Label
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

bath·body·etc®

OCEAN BREEZE

anti-bacterial foaming 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

SATISFACTION GUARANTEED BY REFUND OR EXCHANGE

Bottle Label
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

bath·body·etc®

WARM VANILLA SUGAR

anti-bacterial foaming 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

SATISFACTION GUARANTEED BY REFUND OR EXCHANGE

Bottle Label
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

bath·body·etc®

DARK RASPBERRY

anti-bacterial foaming 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

SATISFACTION GUARANTEED BY REFUND OR EXCHANGE

Bottle Label
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

bath·body·etc®

RED POMEGRANATE

anti-bacterial foaming 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

SATISFACTION GUARANTEED BY REFUND OR EXCHANGE

Bottle Label
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

bath·body·etc®

limited edition
autumn orange

anti-bacterial foaming 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

SATISFACTION GUARANTEED BY REFUND OR EXCHANGE

Bottle Label
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

bath·body·etc®

limited edition
enchanted woods

anti-bacterial foaming 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

SATISFACTION GUARANTEED BY REFUND OR EXCHANGE

Bottle Label

INGREDIENTS AND APPEARANCE

SHOPKO ANTIBACTERIAL FOAMING HAND SANITIZER
triclosan gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50988-296
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
ACETYL TRIETHYLHEXYL CITRATE (UNII: 150CTM9A3J)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SULISOBENZONE (UNII: 1W6L629B4K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50988-296-00	300 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/07/2012

SHOPKO ANTIBACTERIAL FOAMING HAND SANITIZER
triclosan gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50988-297
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
ACETYL TRIETHYLHEXYL CITRATE (UNII: 150CTM9A3J)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SULISOBENZONE (UNII: 1W6L629B4K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50988-297-00	300 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/07/2012

SHOPKO ANTIBACTERIAL FOAMING HAND SANITIZER
triclosan gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50988-298
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
ACETYL TRIETHYLHEXYL CITRATE (UNII: 150CTM9A3J)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SULISOBENZONE (UNII: 1W6L629B4K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50988-298-00	300 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/07/2012

SHOPKO ANTIBACTERIAL FOAMING HAND SANITIZER
triclosan gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50988-299
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
ACETYL TRIETHYLHEXYL CITRATE (UNII: 150CTM9A3J)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SULISOBENZONE (UNII: 1W6L629B4K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50988-299-00	300 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/07/2012

SHOPKO ANTIBACTERIAL FOAMING HAND SANITIZER
triclosan gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50988-300
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
ACETYL TRIETHYLHEXYL CITRATE (UNII: 150CTM9A3J)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SULISOBENZONE (UNII: 1W6L629B4K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50988-300-00	300 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/07/2012

SHOPKO ANTIBACTERIAL FOAMING HAND SANITIZER
triclosan gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50988-301
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
ACETYL TRIETHYLHEXYL CITRATE (UNII: 150CTM9A3J)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SULISOBENZONE (UNII: 1W6L629B4K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50988-301-00	300 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/07/2012

SHOPKO ANTIBACTERIAL FOAMING HAND SANITIZER
triclosan gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50988-302
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
ACETYL TRIETHYLHEXYL CITRATE (UNII: 150CTM9A3J)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SULISOBENZONE (UNII: 1W6L629B4K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50988-302-00	300 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/07/2012

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

Name	Address	ID/FEI	Business Operations
Establishment
Gold Orient International Limited		679905914	MANUFACTURE(50988-296, 50988-297, 50988-298, 50988-299, 50988-300, 50988-301, 50988-302)

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	RxCUI	RxNorm NAME	RxTTY
1	260054	triclosan 0.3 % Medicated Liquid Soap	PSN
2	260054	triclosan 3 MG/ML Medicated Liquid Soap	SCD
3	260054	triclosan 0.3 % Foaming Medicated Hand Soap	SY
4	260054	triclosan 0.3 % Medicated Liquid Soap	SY

	NDC
1	50988-296-00 (inactivated)
2	50988-297-00 (inactivated)
3	50988-298-00 (inactivated)
4	50988-299-00 (inactivated)
5	50988-300-00 (inactivated)
6	50988-301-00 (inactivated)
7	50988-302-00 (inactivated)

Label: SHOPKO ANTIBACTERIAL FOAMING HAND SANITIZER- triclosan gel

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Safety

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More Info For This Drug

Drug Label Information

When using this product

Stop use and ask a doctor

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

Label: SHOPKO ANTIBACTERIAL FOAMING HAND SANITIZER- triclosan gel

View Package Photos

VIEW MORE

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

When using this product

Stop use and ask a doctor

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

SHOPKO ANTIBACTERIAL FOAMING HAND SANITIZER- triclosan gel

Number of versions: 1

SHOPKO ANTIBACTERIAL FOAMING HAND SANITIZER- triclosan gel

SHOPKO ANTIBACTERIAL FOAMING HAND SANITIZER- triclosan gel

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SHOPKO ANTIBACTERIAL FOAMING HAND SANITIZER- triclosan gel

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.