Label: ANTIBACTERIAL HAND SOAP- triclosan solution
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Contains inactivated NDC Code(s)
NDC Code(s): 50988-210-00, 50988-211-00, 50988-212-00, 50988-213-00, view more50988-214-00, 50988-215-00, 50988-216-00 - Packager: Jets, Sets, & Elephants Beauty Corp.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 2, 2010
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- Active ingredient
- Purpose
- Uses
- Warnings
- Directions
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Inactive Ingredients
Warm Vanilla Sugar
Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Sodium Chloride, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Blue 1, Yellow 5
Sweet Cherry Blossom
Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Sodium Chloride, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Yellow 5
Fresh Ocean Breeze
Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Sodium Chloride, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Blue 1, Yellow 5
Cool Cucumber Melon
Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Sodium Chloride, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Yellow 5
Irresistible Green Apple
Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Sodium Chloride, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate, Blue 1, Yellow 5
Alluring Red Pomegranate
Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Sodium Chloride, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate, Red 40, Red 33, Blue 1
Sparkling White Cranberry
Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DEA, Sodium Chloride, Propylene Glycol, Parfum, DMDM Hydantoin, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Citric Acid, Disodium EDTA, Benzophenone-4, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Yellow 5
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INGREDIENTS AND APPEARANCE
ANTIBACTERIAL HAND SOAP
triclosan solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50988-210 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 0.994 mL in 331.22 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) COCO DIETHANOLAMIDE (UNII: 92005F972D) SODIUM CHLORIDE (UNII: 451W47IQ8X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DMDM HYDANTOIN (UNII: BYR0546TOW) ALOE VERA LEAF (UNII: ZY81Z83H0X) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) SULISOBENZONE (UNII: 1W6L629B4K) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50988-210-00 331.22 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333 08/03/2010 ANTIBACTERIAL HAND SOAP
triclosan solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50988-211 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 0.994 mL in 331.22 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) COCO DIETHANOLAMIDE (UNII: 92005F972D) SODIUM CHLORIDE (UNII: 451W47IQ8X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DMDM HYDANTOIN (UNII: BYR0546TOW) ALOE VERA LEAF (UNII: ZY81Z83H0X) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) SULISOBENZONE (UNII: 1W6L629B4K) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) 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:50988-211-00 331.22 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333 08/03/2010 ANTIBACTERIAL HAND SOAP
triclosan solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50988-212 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 0.994 mL in 331.22 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) COCO DIETHANOLAMIDE (UNII: 92005F972D) SODIUM CHLORIDE (UNII: 451W47IQ8X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DMDM HYDANTOIN (UNII: BYR0546TOW) ALOE VERA LEAF (UNII: ZY81Z83H0X) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) SULISOBENZONE (UNII: 1W6L629B4K) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50988-212-00 331.22 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333 08/03/2010 ANTIBACTERIAL HAND SOAP
triclosan solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50988-213 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 0.994 mL in 331.22 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) COCO DIETHANOLAMIDE (UNII: 92005F972D) SODIUM CHLORIDE (UNII: 451W47IQ8X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DMDM HYDANTOIN (UNII: BYR0546TOW) ALOE VERA LEAF (UNII: ZY81Z83H0X) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) SULISOBENZONE (UNII: 1W6L629B4K) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) 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:50988-213-00 331.22 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333 08/03/2010 ANTIBACTERIAL HAND SOAP
triclosan solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50988-214 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 0.994 mL in 331.22 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) COCO DIETHANOLAMIDE (UNII: 92005F972D) SODIUM CHLORIDE (UNII: 451W47IQ8X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DMDM HYDANTOIN (UNII: BYR0546TOW) ALOE VERA LEAF (UNII: ZY81Z83H0X) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) SULISOBENZONE (UNII: 1W6L629B4K) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50988-214-00 331.22 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333 08/03/2010 ANTIBACTERIAL HAND SOAP
triclosan solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50988-215 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 0.994 mL in 331.22 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) COCO DIETHANOLAMIDE (UNII: 92005F972D) SODIUM CHLORIDE (UNII: 451W47IQ8X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DMDM HYDANTOIN (UNII: BYR0546TOW) ALOE VERA LEAF (UNII: ZY81Z83H0X) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) SULISOBENZONE (UNII: 1W6L629B4K) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) FD&C RED NO. 40 (UNII: WZB9127XOA) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50988-215-00 331.22 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333 08/03/2010 ANTIBACTERIAL HAND SOAP
triclosan solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50988-216 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 0.994 mL in 331.22 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) COCO DIETHANOLAMIDE (UNII: 92005F972D) SODIUM CHLORIDE (UNII: 451W47IQ8X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DMDM HYDANTOIN (UNII: BYR0546TOW) ALOE VERA LEAF (UNII: ZY81Z83H0X) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) SULISOBENZONE (UNII: 1W6L629B4K) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) 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:50988-216-00 331.22 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333 08/03/2010 Labeler - Jets, Sets, & Elephants Beauty Corp. (243254039) Establishment Name Address ID/FEI Business Operations Gold Orient International Limited 679905914 MANUFACTURE
