Label: LONIMAX HAND SANITISING- alcohol gel

  • 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 May 2, 2020

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  • SPL UNCLASSIFIED SECTION

    NA

  • Active Ingredient(s)

    Alcohol 75% 

  • Purpose

    Antiseptic

  • Use

    For hand washing to help decrease bacteria on the skin only when water is not available

  • Warnings

    For external use only. Flammable. Keep away from fire and flame

  • WHEN USING

    When using this product do not get into eyes. When contact occurs, rinse eyes thoroughly with water

    May discolor fabrics

  • STOP USE

    Stop use and ask a doctor if irritation and redness develop

  • 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

    • Wet hands thoroughly with product and allow to dry without wiping
  • Other information

    • Store below 105F
  • Inactive ingredients

    Water, Carbomer, Xanthan Gum, glycerin, Aloe Vera Extract, Allantoin, Vitamin E, Cellulose, Lactose, Jojoba Alcohol, Hyfrogenated

  • Package Label - Principal Display Panel

    c

  • INGREDIENTS AND APPEARANCE
    LONIMAX HAND SANITISING 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75556-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 934 (UNII: Z135WT9208)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALPHA CELLULOSE (UNII: I355QGZ19A)  
    .ALPHA.-LACTOSE (UNII: MJF4JAT10B)  
    HYDROGENATED JOJOBA OIL (UNII: 7F674YQ5SO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75556-001-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/19/2020
    2NDC:75556-001-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product04/19/2020
    3NDC:75556-001-03237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/19/2020
    4NDC:75556-001-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/19/2020
    5NDC:75556-001-051000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/19/2020
    Labeler - ZHEJIANG SHUNAN INDUSTRY&TRADE CO., LTD (528198838)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZHEJIANG SHUNAN INDUSTRY&TRADE CO., LTD528198838manufacture(75556-001)
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