Label: HAND SANITIZER- alcohol solution
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Contains inactivated NDC Code(s)
NDC Code(s): 75539-003-03 - Packager: LiDestri Beverages, LLC
- 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 18, 2020
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- Official Label (Printer Friendly)
- DOSAGE & ADMINISTRATION
- WARNINGS
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- ACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75539-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) LINALOOL, (+/-)- (UNII: D81QY6I88E) 0.007 mL in 100 mL BENZYL BENZOATE (UNII: N863NB338G) 0.008 mL in 100 mL METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y) 0.008 mL in 100 mL LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.036 mL in 100 mL ETHYL MALTOL (UNII: L6Q8K29L05) 0.004 mL in 100 mL ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD) 0.004 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL in 100 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL in 100 mL .ALPHA.-METHYLBENZYL ACETATE (UNII: FYS3E9NBA3) 0.003 mL in 100 mL .GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL) 0.003 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75539-003-03 3780 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/18/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/18/2020 Labeler - LiDestri Beverages, LLC (151558413)
