Label: HAND SANITIZER- alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 75009-680-01, 75009-680-02, 75009-680-03, 75009-680-04, view more75009-680-05 - Packager: Alpha Aromatics
- 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 January 21, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
The hand sanitizer is manufactured using only the following ingredients:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- Sterile distilled water or boiled cold water.
- Fragrance
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
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WHEN USING
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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. If swallowed, get medical help or contact a Poison Control Center right away. - STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75009-680 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 DIHYDROMYRCENOL (UNII: 46L1B02ND9) 0.02 mL in 100 mL 4-TERT-BUTYLCYCLOHEXYL ACETATE (UNII: 21EUM2B8UC) 0.01 mL in 100 mL .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) 0.005 mL in 100 mL LINALOOL, (+/-)- (UNII: D81QY6I88E) 0.05 mL in 100 mL BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) 0.02 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL in 100 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL in 100 mL WATER (UNII: 059QF0KO0R) EUCALYPTUS OIL (UNII: 2R04ONI662) 0.03 mL in 100 mL PIPERONAL (UNII: KE109YAK00) 0.005 mL in 100 mL LINALYL ACETATE (UNII: 5K47SSQ51G) 0.07 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75009-680-01 208190 mL in 1 DRUM; Type 0: Not a Combination Product 03/30/2020 2 NDC:75009-680-02 1040980 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product 03/30/2020 3 NDC:75009-680-03 18920 mL in 1 PAIL; Type 0: Not a Combination Product 03/30/2020 4 NDC:75009-680-04 3780 mL in 1 JUG; Type 0: Not a Combination Product 03/30/2020 5 NDC:75009-680-05 946 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 Labeler - Alpha Aromatics (041723545) Establishment Name Address ID/FEI Business Operations Alpha Aromatics 041723545 manufacture(75009-680)