Label: TOUGH TOWN HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77340-002-01, 77340-002-02, 77340-002-03, 77340-002-04 - Packager: 28 MILE DISTILLING COMPANY, 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 October 2, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
- Directions
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Inactive ingredients
Polyethylene glycol,1, 2, 3-Propanetriol, 1 ,3-Propanediamine, Benzyl benzoate, D-Limonene, .alpha.-Pinene, Hydrogen peroxide, Octanal, 2- (phenylmethylene), Oils (Siberian Fir, Citral, Geraniol Oils, Lemon, Juniper, Ethanone, Oils, Coriander, Sweet Orange, Petitgrain, Citronella, Citronellol, Geranium, Eucalyptus, Mandarin, Lime, Camphor oil, Linalool, Cyclohexanone
- SPL UNCLASSIFIED SECTION
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
TOUGH TOWN HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77340-002 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 WATER (UNII: 059QF0KO0R) HYDROGEN PEROXIDE (UNII: BBX060AN9V) GLYCERIN (UNII: PDC6A3C0OX) 1,2,3-PROPANETRIOL, 2-(4-AMINOBENZOATE) (UNII: 3S4077U0T0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77340-002-01 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/04/2020 2 NDC:77340-002-02 89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/04/2020 3 NDC:77340-002-03 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/04/2020 4 NDC:77340-002-04 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/04/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/04/2020 Labeler - 28 MILE DISTILLING COMPANY, LLC (107153056) Establishment Name Address ID/FEI Business Operations 28 MILE DISTILLING COMPANY, LLC 107153056 manufacture(77340-002)