Label: OMEDI HAND SANITIZER- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 74646-0080-1 - Packager: Natural Korea 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 April 20, 2020
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INGREDIENTS AND APPEARANCE
OMEDI HAND SANITIZER
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74646-0080 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 56 mL in 80 mL Inactive Ingredients Ingredient Name Strength ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MENTHOL (UNII: L7T10EIP3A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) GREEN TEA LEAF (UNII: W2ZU1RY8B0) WATER (UNII: 059QF0KO0R) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) ARGININE (UNII: 94ZLA3W45F) GRAPEFRUIT (UNII: O82C39RR8C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74646-0080-1 80 mL in 1 TUBE; Type 0: Not a Combination Product 04/20/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/16/2020 Labeler - Natural Korea Co., Ltd. (688729438) Establishment Name Address ID/FEI Business Operations Natural Korea Co., Ltd. 688729438 manufacture(74646-0080)