Label: LEMYN ORGANICS MEDICAL GRADE HAND SANITIZER GEL- hand sanitizer 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 7, 2021

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  • Active Ingredient

    -

    Active Ingredient

    Ethyl Alcohol 70% v/v

    Purpose

    Antiseptic

  • Uses

    Health care personnel + consumer grade 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

    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 appears and lasts

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

    Do not use

    • With children less than 2 months of age
    • On open skin wounds
  • Directions

    • Put enough product in your palm to cover hands. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product.
    • Avoid swallowing.
  • Inactive Ingredients

    JOJOBA OIL (UNII: 724GKU717M)

    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

    ORANGE OIL (UNII: AKN3KSD11B)

    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

    GLYCERIN (UNII: PDC6A3C0OX)

    ALOE VERA LEAF (UNII: ZY81Z83H0X)

    HYALURONATE SODIUM (UNII: YSE9PPT4TH)

    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

    COMFREY ROOT (UNII: M9VVZ08EKQ)

    SUNFLOWER OIL (UNII: 3W1JG795YI)

    PANTHENOL (UNII: WV9CM0O67Z)

    AVOCADO OIL (UNII: 6VNO72PFC1)

    WATER (UNII: 059QF0KO0R)

  • Other Information

    • Store below 104F (40C)
    • Avoid freezing and excessive heat above 104F (40C)
    • May discolor certain fabrics or sufaces.
  • Questions and Comments?

    Call 877-262-1971

  • Dosage and Administration

    Put enough product in your palm to cover hands. Rub hands together until dry.

    Supervise children under 6 years of age when using this product.
    Avoid swallowing.

  • Indications and Usage

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

    Put enough product in your palm to cover hands. Rub hands together until dry.
    Supervise children under 6 years of age when using this product.
    Avoid swallowing.

  • 2 fl oz Label

    59 mL NDC: 67923-101-02

    59 ml label

  • COMPANY INFORMATION

    Distributed by Lemyn, LLC

    Santa Barbara, CA 93108

    Questions or comments?

    Visit lemyn.com

  • INGREDIENTS AND APPEARANCE
    LEMYN ORGANICS MEDICAL GRADE HAND SANITIZER GEL 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67923-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYALURONATE SODIUM (UNII: YSE9PPT4TH) 0.001 mL  in 100 mL
    JOJOBA OIL (UNII: 724GKU717M) 0.001 mL  in 100 mL
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ) 0.04275 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 28.28725 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 1.0075 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0025 mL  in 100 mL
    SUNFLOWER OIL (UNII: 3W1JG795YI) 0.001 mL  in 100 mL
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.001 mL  in 100 mL
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.33 mL  in 100 mL
    ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B) 0.3 mL  in 100 mL
    AVOCADO OIL (UNII: 6VNO72PFC1) 0.001 mL  in 100 mL
    PANTHENOL (UNII: WV9CM0O67Z) 0.025 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67923-101-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product10/28/2020
    2NDC:67923-101-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product10/28/2020
    3NDC:67923-101-12355 mL in 1 BOTTLE; Type 0: Not a Combination Product10/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/28/2020
    Labeler - Vege Labs LLC. (117878620)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vege Labs LLC.117878620manufacture(67923-101)
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