Label: ZEROTH PREMIUM HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78393-010-01 - Packager: Biocleansingcompany 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 May 27, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENTS
Water, Carbomer, Tetrahydroxypropyl Ethylenediamine, Tocopheryl Acetate, Lavandula Angustifolia (Lavender) Oil, Fragaria Chiloensis (Strawberry) Fruit Extract, Sophora Angustifolia Root Extract, Morus Alba Bark Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Citrus Paradisi (Grapefruit) Fruit Extract, Camellia Sinensis Leaf Extract, Cnidium Officinate Rhizome Extract
- Purpose
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Warnings
For external use only. Flammable. Keep away from heat or flame
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Do not use
• in children less than 2 months of age
• on open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. - KEEP OUT OF REACH OF CHILDREN
- Uses
- Directions
- Other information
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ZEROTH PREMIUM HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78393-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 350 mL in 500 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) EDETOL (UNII: Q4R969U9FR) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) LAVENDER OIL (UNII: ZBP1YXW0H8) BEACH STRAWBERRY (UNII: 98542F2TQS) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) MORUS ALBA BARK (UNII: 7O71A48NDP) GLYCYRRHIZA URALENSIS ROOT (UNII: 42B5YD8F0K) GRAPEFRUIT (UNII: O82C39RR8C) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CNIDIUM OFFICINALE ROOT (UNII: 8S3OZD358J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78393-010-01 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 05/01/2020 Labeler - Biocleansingcompany Co., Ltd (695538805) Registrant - Biocleansingcompany Co., Ltd (695538805) Establishment Name Address ID/FEI Business Operations DongbangCosmetics Co., ltd. 694452564 manufacture(78393-010)
