Label: ZERO-PERCENT PORTABLE SANITIZER- alcohol kit
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Contains inactivated NDC Code(s)
NDC Code(s): 74004-047-02 - Packager: Ester Co., Ltd.
- 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 October 6, 2020
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INGREDIENTS AND APPEARANCE
ZERO-PERCENT PORTABLE SANITIZER
alcohol kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74004-047 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74004-047-02 1 in 1 BOX 10/07/2020 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, SPRAY 40 mL Part 2 1 BOTTLE, SPRAY 40 mL Part 3 1 BOTTLE, SPRAY 40 mL Part 4 1 BOTTLE, SPRAY 40 mL Part 5 1 BOTTLE, SPRAY 40 mL Part 1 of 5 ZERO-PERCENT PORTABLE SANITIZER
alcohol sprayProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 28 mL in 40 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 40 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/07/2020 Part 2 of 5 ZERO-PERCENT PORTABLE SANITIZER
alcohol sprayProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 28 mL in 40 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 40 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/07/2020 Part 3 of 5 ZERO-PERCENT PORTABLE SANITIZER
alcohol sprayProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 28 mL in 40 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 40 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/07/2020 Part 4 of 5 ZERO-PERCENT PORTABLE SANITIZER
alcohol sprayProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 28 mL in 40 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 40 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/07/2020 Part 5 of 5 ZERO-PERCENT PORTABLE SANITIZER
alcohol sprayProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 28 mL in 40 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 40 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/07/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/07/2020 Labeler - Ester Co., Ltd. (688425766) Establishment Name Address ID/FEI Business Operations Ester Co., Ltd. 688425766 manufacture(74004-047)