Label: ANTIBACTERIAL FOAMING HAND SANITIZER- benzalkonium chloride solution
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Contains inactivated NDC Code(s)
NDC Code(s): 50988-190-00, 50988-191-00, 50988-192-00, 50988-193-00, view more50988-194-00, 50988-195-00, 50988-196-00, 50988-197-00, 50988-198-00 - 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 November 24, 2010
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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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
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Inactive Ingredients
Warm Vanilla Sugar
Aqua, Alcohol, Decyl Glucoside, Parfum, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Disodium EDTA, Benzophenone-4, Citric Acid, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Blue 1, Yellow 5
Sweet Cherry Blossom
Aqua, Alcohol, Decyl Glucoside, Parfum, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Disodium EDTA, Benzophenone-4, Citric Acid, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Yellow 5
Fresh Ocean Breeze
Aqua, Alcohol, Decyl Glucoside, Parfum, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Disodium EDTA, Benzophenone-4, Citric Acid, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Blue 1, Yellow 5
Cool Cucumber Melon
Aqua, Alcohol, Decyl Glucoside, Parfum, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Disodium EDTA, Benzophenone-4, Citric Acid, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Yellow 5
Irresistible Green Apple
Aqua, Alcohol, Decyl Glucoside, Parfum, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Disodium EDTA, Benzophenone-4, Citric Acid, Tocopheryl Acetate, Retinyl Palmitate, Blue 1, Yellow 5
Alluring Red Pomegranate
Aqua, Alcohol, Decyl Glucoside, Parfum, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Disodium EDTA, Benzophenone-4, Citric Acid, Tocopheryl Acetate, Retinyl Palmitate, Red 40, Red 33, Blue 1
Sparkling White Cranberry
Aqua, Alcohol, Decyl Glucoside, Parfum, Aloe Barbadensis, Methylisothiazolinone, Methylchloroisothiazolinone, Disodium EDTA, Benzophenone-4, Citric Acid, Tocopheryl Acetate, Retinyl Palmitate, Red 33, Yellow 5
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INGREDIENTS AND APPEARANCE
ANTIBACTERIAL FOAMING HAND SANITIZER
benzalkonium chloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50988-190 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.055 mL in 50.275 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) ALOE VERA LEAF (UNII: ZY81Z83H0X) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) SULISOBENZONE (UNII: 1W6L629B4K) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) .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:50988-190-00 50.275 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333E 08/03/2010 ANTIBACTERIAL FOAMING HAND SANITIZER
benzalkonium chloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50988-191 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.055 mL in 50.275 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) ALOE VERA LEAF (UNII: ZY81Z83H0X) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) SULISOBENZONE (UNII: 1W6L629B4K) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) .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:50988-191-00 50.275 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333E 08/03/2010 ANTIBACTERIAL FOAMING HAND SANITIZER
benzalkonium chloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50988-192 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.055 mL in 50.275 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) ALOE VERA LEAF (UNII: ZY81Z83H0X) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) SULISOBENZONE (UNII: 1W6L629B4K) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) .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:50988-192-00 50.275 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333E 08/03/2010 ANTIBACTERIAL FOAMING HAND SANITIZER
benzalkonium chloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50988-193 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.055 mL in 50.275 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) ALOE VERA LEAF (UNII: ZY81Z83H0X) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) SULISOBENZONE (UNII: 1W6L629B4K) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) .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:50988-193-00 50.275 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333E 08/03/2010 ANTIBACTERIAL FOAMING HAND SANITIZER
benzalkonium chloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50988-194 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.055 mL in 50.275 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) ALOE VERA LEAF (UNII: ZY81Z83H0X) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) SULISOBENZONE (UNII: 1W6L629B4K) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) .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:50988-194-00 50.275 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333E 08/03/2010 ANTIBACTERIAL FOAMING HAND SANITIZER
benzalkonium chloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50988-195 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.055 mL in 50.275 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) ALOE VERA LEAF (UNII: ZY81Z83H0X) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) SULISOBENZONE (UNII: 1W6L629B4K) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) .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:50988-195-00 50.275 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333E 08/03/2010 ANTIBACTERIAL FOAMING HAND SANITIZER
benzalkonium chloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50988-196 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.055 mL in 50.275 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) ALOE VERA LEAF (UNII: ZY81Z83H0X) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) SULISOBENZONE (UNII: 1W6L629B4K) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) .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:50988-196-00 50.275 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333E 08/03/2010 ANTIBACTERIAL FOAMING HAND SANITIZER
benzalkonium chloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50988-197 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.055 mL in 50.275 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) ALOE VERA LEAF (UNII: ZY81Z83H0X) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) SULISOBENZONE (UNII: 1W6L629B4K) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) .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:50988-197-00 50.275 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333E 12/01/2010 ANTIBACTERIAL FOAMING HAND SANITIZER
benzalkonium chloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50988-198 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.055 mL in 50.275 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) ALOE VERA LEAF (UNII: ZY81Z83H0X) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) SULISOBENZONE (UNII: 1W6L629B4K) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) .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) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50988-198-00 50.275 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333E 12/01/2010 Labeler - Jets, Sets, & Elephants Beauty Corp. (243254039) Establishment Name Address ID/FEI Business Operations Gold Orient International Limited 679905914 MANUFACTURE