Label: SANILUXE HAND SANITIZER ALCOHOL FREE- benzalkonium chloride gel

  • NDC Code(s): 71489-008-01, 71489-008-02, 71489-008-03, 71489-008-04, view more
    71489-008-05, 71489-008-06, 71489-008-07, 71489-008-08, 71489-008-09, 71489-008-10, 71489-008-11, 71489-008-12, 71489-008-13, 71489-008-14, 71489-008-15, 71489-008-16
  • Packager: Celeste Industries Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 8, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzalkonium Chloride 0.1%

  • Purpose

    Antimicrobial

  • Uses

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

    • For external use only.

    • Keep out of reach of children.

    • When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

    • Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.
    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Pump a small amount of gel into palm of hand
    • Rub hands together briskly until dry
    • Rub thoroughly over all surfaces of both hands
  • Inactive ingredients

    Water (Aqua), Triethylene Glycol, Glycereth-26, Cocamidopropyl PG-Dimonium Cloride Phosphate,Hydroxyethylcellulose, DMDM Hydantoin, Triethanolamine, Fragrance (Aroma), Iodopropynyl Butyl Carbamate, 1, 3-Butanediol

  • PRINCIPAL DISPLAY PANEL

    SaniLuxe™

    HAND SANITIZER GEL

    Alcohol free

    • 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
    SANILUXE HAND SANITIZER ALCOHOL FREE 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71489-008
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TRIETHYLENE GLYCOL (UNII: 3P5SU53360)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%) (UNII: X70SE62ZAR)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71489-008-01284 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/19/2019
    2NDC:71489-008-02177 mL in 1 BOTTLE; Type 0: Not a Combination Product06/25/2020
    3NDC:71489-008-0359 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/25/2020
    4NDC:71489-008-04237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/25/2020
    5NDC:71489-008-05355 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/25/2020
    6NDC:71489-008-063785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/25/2020
    7NDC:71489-008-0759 mL in 1 BOTTLE; Type 0: Not a Combination Product06/25/2020
    8NDC:71489-008-08177 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/25/2020
    9NDC:71489-008-09237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/25/2020
    10NDC:71489-008-10284 mL in 1 BOTTLE; Type 0: Not a Combination Product06/25/2020
    11NDC:71489-008-11355 mL in 1 BOTTLE; Type 0: Not a Combination Product06/25/2020
    12NDC:71489-008-123785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/25/2020
    13NDC:71489-008-13946 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2020
    14NDC:71489-008-14946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/30/2020
    15NDC:71489-008-15530 mL in 1 BOTTLE; Type 0: Not a Combination Product10/14/2020
    16NDC:71489-008-16530 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)02/19/2019
    Labeler - Celeste Industries Corporation (047795034)
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