Label: SENEGENCE HAND SANITIZER- alcohol 70% liquid

  • 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 March 19, 2021

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  • Active Ingredients

    Alcohol 70% v/v

  • Purpose

    Alcohol 70% v/v.........................Antiseptic

  • Uses

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available

  • Warnings

    For external use only. Flammable. Keep away from heat or flame.

  • DO NOT USE

    Do not use
    • on children less than 2 months of age
    • on open skin wounds

  • 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

    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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.

    • Supervise children under 6 years of age when using this product to avoid swallowing.

  • Other Information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)

  • Inactive Ingredients

    Aqua/Water/Eau, Propanediol, Glycerin, Hydroxypropyl Guar, Nangai (Canarium Indicum) Seed Oil, Aloe Vera (Aloe Barbadensis) Leaf Juice, Kelp (Laminaria Digitata) Extract, Yeast (Saccharomyces Cerevisiae) Extract, Orchid (Orchis Mascula) Flower Extract, Sodium Hyaluronate, Sodium Hyaluronate Crosspolymer-2, Hydrolyzed Sodium Hyaluronate, Sodium Acetylated Hyaluronate, Tocopheryl Acetate, Panthenol, Glucosamine HCl, Retinyl Palmitate, Citric Acid, Denatonium Benzoate, T-Butyl Alcohol, Sodium Hydroxide, Alcohol Denat., Butylene Glycol, Urea*, Pentylene Glycol, Phenoxyethanol, Ethylhexylglycerin, Parfum/Fragrance, Hydroxycitronellal, Benzyl Salicylate, Limonene, Geraniol, Linalool, Isoeugenol. *Synthetic

  • PRINCIPAL DISPLAY PANEL

    PDP

  • INGREDIENTS AND APPEARANCE
    SENEGENCE HAND SANITIZER 
    alcohol 70% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72644-637
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL140 mL  in 200 mL
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    UREA (UNII: 8W8T17847W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CANARIUM INDICUM SEED OIL (UNII: 4UI31S9F33)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    ISOEUGENOL (UNII: 5M0MWY797U)  
    YEAST (UNII: 3NY3SM6B8U)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    GERANIOL (UNII: L837108USY)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    GUARAPROLOSE (1300 MPA.S AT 1%) (UNII: 1530WMS90S)  
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ORCHIS MASCULA FLOWER (UNII: 6H1JQK35LA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72644-637-01118 mL in 1 BOTTLE; Type 0: Not a Combination Product10/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/05/2020
    Labeler - SGII, Inc (070096792)
    Establishment
    NameAddressID/FEIBusiness Operations
    220 Laboratories inc783247950manufacture(72644-637)
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