Label: HAND SANITIZER- ethanol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 73982-000-00, 73982-000-01, 73982-000-02, 73982-000-03, view more73982-000-04, 73982-000-05, 73982-000-06, 73982-000-07 - Packager: Fifth Generation, Inc.
- Category: HUMAN OTC DRUG LABEL
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 August 7, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- Hand Sanitizer
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
ethanol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73982-000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 80 mL in 100 mL Inactive Ingredients Ingredient Name Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73982-000-01 200 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2020 2 NDC:73982-000-00 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2020 3 NDC:73982-000-02 375 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2020 4 NDC:73982-000-03 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2020 5 NDC:73982-000-04 11356 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2020 6 NDC:73982-000-05 18927 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2020 7 NDC:73982-000-06 208197 mL in 1 DRUM; Type 0: Not a Combination Product 03/27/2020 8 NDC:73982-000-07 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/27/2020 Labeler - Fifth Generation, Inc. (961445723) Establishment Name Address ID/FEI Business Operations Fifth Generation, Inc. 961445723 manufacture(73982-000)
