Label: LUOYS HAND SANITIER- 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 April 16, 2020

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  • SPL UNCLASSIFIED SECTION

    NA

  • Active Ingredient(s)

    Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    For hand sanitizing to help decrease bacteria on the skin

    Recommended for repeated use

  • Warnings

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

  • Do not use

    • in 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, flush eyes with water.

  • STOP USE

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

  • 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

    • Pump a small amount into palm of hands
    • Rub thoroughly over all surface of both hands
    • Rub hands together briskly untill dry
  • Other information

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

    Water, propylene glycol, glycerin, carbomer, triethanolamine

  • Package Label - Principal Display Panel

    image description

  • INGREDIENTS AND APPEARANCE
    LUOYS HAND SANITIER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74765-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 934 (UNII: Z135WT9208)  
    TRIETHANOLAMINE SULFATE (UNII: MV1V89M17O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74765-001-0129 mL in 1 BOTTLE; Type 0: Not a Combination Product04/08/2020
    2NDC:74765-001-0250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/16/2020
    3NDC:74765-001-0360 mL in 1 BOTTLE; Type 0: Not a Combination Product04/16/2020
    4NDC:74765-001-04100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/16/2020
    5NDC:74765-001-05300 mL in 1 BOTTLE; Type 0: Not a Combination Product04/16/2020
    6NDC:74765-001-06500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/16/2020
    7NDC:74765-001-071000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/16/2020
    8NDC:74765-001-082000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/16/2020
    9NDC:74765-001-093000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/16/2020
    10NDC:74765-001-105000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/08/2020
    Labeler - ZheJiang Yiwu Limei Cosmetics Co., Ltd (679892245)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZheJiang Yiwu Limei Cosmetics Co., Ltd679892245manufacture(74765-001)