Label: SANI LUXE HAND SANITIZER WITH ALCOHOL- alcohol gel

  • NDC Code(s): 71489-007-01, 71489-007-02, 71489-007-03, 71489-007-04, view more
    71489-007-05, 71489-007-06, 71489-007-07, 71489-007-08, 71489-007-09, 71489-007-10, 71489-007-11, 71489-007-12, 71489-007-13, 71489-007-14, 71489-007-15, 71489-007-16
  • Packager: Celeste Industries Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 11, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Ethyl Alcohol 62.5%

  • Purpose

    Antimicrobial

  • Uses

    • Recommended for repeated use
    • For hand sanitizing to decrease bacteria on the skin
  • Warnings

    • For external use only.
    • Flammable. Keep away from open flame and sources of heat.

    • Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

    • When using this product, avoid contact with eyes. In case of eye contact, flush eyes with water.
    • If swallowed, get medical help or contact a Poison Control Center right away.

    • Keep out of reach of children.
  • Directions

    • Children under 6 years of age should be supervised when using this product
    • Place enough product in your palm to thoroughly cover your hands
    • Rub hands together briskly until dry
  • Other information

    • Store below 110°F (43°C)
    • May discolor certain fabrics or surfaces.
  • Inactive ingredients

    Aqua, PEG-4 Diheptanoate, Acrylates/C10-30 Alkyl Acrylate crosspolymer, Fragrance, Aminomethyl Propanol

    May contain hydroxypropylcellulose.

  • 284 ml Bottle Label

    Sani Luxe ®

    HAND SANITIZER GEL

    with Alcohol

    • Requires no water or towels.
    • Apply small amount to hands

      and rub until dry.

    Kills 99%

    of germs

    on contact

    Caution: Use on hands only.

    284ml e

    PRINCIPAL DISPLAY PANEL - 284 ml Bottle Label

  • INGREDIENTS AND APPEARANCE
    SANI LUXE HAND SANITIZER WITH ALCOHOL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71489-007
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.625 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PEG-4 DIHEPTANOATE (UNII: 2DQ7O61VHJ)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71489-007-01284 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/24/2019
    2NDC:71489-007-02177 mL in 1 BOTTLE; Type 0: Not a Combination Product03/25/202011/14/2022
    3NDC:71489-007-0359 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/25/2020
    4NDC:71489-007-04237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/20/202011/14/2022
    5NDC:71489-007-05355 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/25/202011/14/2022
    6NDC:71489-007-063785 mL in 1 BOTTLE; Type 0: Not a Combination Product03/25/202011/14/2022
    7NDC:71489-007-0759 mL in 1 BOTTLE; Type 0: Not a Combination Product06/25/2020
    8NDC:71489-007-08177 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/25/202011/14/2022
    9NDC:71489-007-09237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/25/202011/14/2022
    10NDC:71489-007-10284 mL in 1 BOTTLE; Type 0: Not a Combination Product06/25/2020
    11NDC:71489-007-11355 mL in 1 BOTTLE; Type 0: Not a Combination Product06/25/202011/14/2022
    12NDC:71489-007-123785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/25/202011/14/2022
    13NDC:71489-007-13946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/30/2020
    14NDC:71489-007-14946 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2020
    15NDC:71489-007-15530 mL in 1 BOTTLE; Type 0: Not a Combination Product10/14/2020
    16NDC:71489-007-16530 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/14/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)01/24/2019
    Labeler - Celeste Industries Corporation (047795034)
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