Label: HAND SANITIZER- ethyl alcohol gel
- NDC Code(s): 72866-103-01
- Packager: Merci Handy Corporation
- 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 February 23, 2019
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients
water(aqua), aloe vera leaf juice, glycerin, propylene glycol, fragrance(parfum), acrylates/C30-10 alkyl acrylate crosspolymer, aminomethyl propanol, mannitol, microcrystalline cellulose, sucrose, corn(zea mays) starch, hydroxpropyl methyl cellulose, tocopheryl acetate, denatonium benzonate, maltodextrin, alpha-isomethyl ionone, amyl cinnamal, amylcinnamyl alcohol, benzyl salicylate, hexyl cinnamal, Iron Oxides, FD&C Red No.4, FD&C Yellow No.5.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72866-103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 67 mL in 100 mL Inactive Ingredients Ingredient Name Strength .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) .ALPHA.-IONONE (UNII: I9V075M61R) BENZYL SALICYLATE (UNII: WAO5MNK9TU) DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) MALTODEXTRIN (UNII: 7CVR7L4A2D) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) MANNITOL (UNII: 3OWL53L36A) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SUCROSE (UNII: C151H8M554) STARCH, CORN (UNII: O8232NY3SJ) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HYPROMELLOSES (UNII: 3NXW29V3WO) FD&C RED NO. 4 (UNII: X3W0AM1JLX) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) .ALPHA.-AMYLCINNAMYL ALCOHOL (UNII: DKB52S61GU) BROWN IRON OXIDE (UNII: 1N032N7MFO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72866-103-01 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/18/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 02/18/2019 Labeler - Merci Handy Corporation (116958007)