Label: SHOPKO ANTIBACTERIAL HAND SANITIZER- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 50988-288-00, 50988-289-00, 50988-400-00, 50988-401-00, view more50988-402-00 - 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 June 28, 2012
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- Active Ingredient
- Purpose
- Use
- Warnings
- Directions
- Inactive ingredients (Ocean Breeze)
- Inactive ingredients (Cherry Blossom)
- Inactive ingredients (Red Pomegranate)
- Inactive ingredients (Dark Raspberry)
- Inactive ingredients (Warm Vanilla Sugar)
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INGREDIENTS AND APPEARANCE
SHOPKO ANTIBACTERIAL HAND SANITIZER
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50988-288 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.62 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO) POLYSORBATE 20 (UNII: 7T1F30V5YH) TROLAMINE (UNII: 9O3K93S3TK) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) LACTOSE (UNII: J2B2A4N98G) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ULTRAMARINE BLUE (UNII: I39WR998BI) 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:50988-288-00 30 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 06/21/2012 SHOPKO ANTIBACTERIAL HAND SANITIZER
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50988-289 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.62 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO) POLYSORBATE 20 (UNII: 7T1F30V5YH) TROLAMINE (UNII: 9O3K93S3TK) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) LACTOSE (UNII: J2B2A4N98G) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ULTRAMARINE BLUE (UNII: I39WR998BI) 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:50988-289-00 30 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 06/21/2012 SHOPKO ANTIBACTERIAL HAND SANITIZER
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50988-400 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.62 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO) POLYSORBATE 20 (UNII: 7T1F30V5YH) TROLAMINE (UNII: 9O3K93S3TK) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) LACTOSE (UNII: J2B2A4N98G) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 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:50988-400-00 30 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 06/21/2012 SHOPKO ANTIBACTERIAL HAND SANITIZER
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50988-401 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.62 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO) POLYSORBATE 20 (UNII: 7T1F30V5YH) TROLAMINE (UNII: 9O3K93S3TK) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) LACTOSE (UNII: J2B2A4N98G) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 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:50988-401-00 30 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 06/21/2012 SHOPKO ANTIBACTERIAL HAND SANITIZER
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50988-402 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.62 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO) POLYSORBATE 20 (UNII: 7T1F30V5YH) TROLAMINE (UNII: 9O3K93S3TK) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) LACTOSE (UNII: J2B2A4N98G) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ULTRAMARINE BLUE (UNII: I39WR998BI) 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:50988-402-00 30 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 06/21/2012 Labeler - Jets, Sets, & Elephants Beauty Corp. (243254039) Establishment Name Address ID/FEI Business Operations Gold Orient International Limited 679905914 MANUFACTURE(50988-288, 50988-289, 50988-400, 50988-401, 50988-402)