Label: LECHAT- hand sanitizer gel 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 October 24, 2022

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  • Active Ingredient(s)

    Ethyl Alcohol 65% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria.

  • 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, rinse eyes thoroughly with water.
    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. If swallowed, get medical help or contact a Poison Control Center right away.

  • 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

    • Wet hands thoroughly with the product and rub it on the skin untill dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

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

    glycerin, hydrogen peroxide, purified water, isopropyl alcohol, hydroxypropyl methylcellulose, dl alpha-tocopheryl acetate, Aloe barbadensis leaf extract, Lavandula Angustifolia oil, citrus Aurantium Dulcis peel, citrus paradisi peel oil, Fragrance

  • Package Label - Principal Display Panel

    60mL NDC: 77857-812-0260mL NDC: 77857-812-02

  • INGREDIENTS AND APPEARANCE
    LECHAT 
    hand sanitizer gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77857-812
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CITRUS PARADISI FRUIT OIL (UNII: 6A7N43E0OJ)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    ORANGE PEEL (UNII: TI9T76XD44)  
    FRAGRANCE GREEN APPLE ORC2001072 (UNII: U9GH30P956)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77857-812-0151 mL in 1 BOTTLE; Type 0: Not a Combination Product05/22/2020
    2NDC:77857-812-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product05/22/2020
    3NDC:77857-812-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/22/2020
    4NDC:77857-812-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product05/22/2020
    5NDC:77857-812-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product05/22/2020
    6NDC:77857-812-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product05/22/2020
    7NDC:77857-812-283780 mL in 1 BOTTLE; Type 0: Not a Combination Product05/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/22/2020
    Labeler - Mega Creation Inc. (014096208)
    Registrant - Mega Creation Inc. (014096208)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mega Creation Inc.014096208manufacture(77857-812)
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