Label: O2 CLEAN HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 80453-010-01 - Packager: O2 Clean
- 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 September 15, 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
Acorus Calamus Root Extract, Camellia Sinensis Leaf Extract, Carbomer, Citrus Paradisi (Grapefruit) Fruit Extract, Cnidium Officinale Rhizome Extract, Fragaria Chiloensis (Strawberry) Fruit Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Lavandula Angustifolia (Lavender) Oil, Morus Alba Bark Extract, Sophora Angustifolia Root Extract, Tetrahydroxypropyl Ethylenediamine, Tocopheryl Acetate, Water
- 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
O2 CLEAN HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80453-010 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 ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) GRAPEFRUIT (UNII: O82C39RR8C) CNIDIUM OFFICINALE ROOT (UNII: 8S3OZD358J) BEACH STRAWBERRY (UNII: 98542F2TQS) GLYCYRRHIZA URALENSIS ROOT (UNII: 42B5YD8F0K) LAVENDER OIL (UNII: ZBP1YXW0H8) MORUS ALBA BARK (UNII: 7O71A48NDP) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) EDETOL (UNII: Q4R969U9FR) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80453-010-01 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 09/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/01/2020 Labeler - O2 Clean (694888055) Registrant - O2 Clean (694888055) Establishment Name Address ID/FEI Business Operations DongbangCosmetics Co., ltd. 694452564 manufacture(80453-010)
