Label: AMASS LAVENDER AND FIR HAND SANITIZER- lavender and fir hand sanitizer liquid

  • Category: HUMAN OTC DRUG LABEL

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 November 10, 2020

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  • ACTIVE INGREDIENT

    Active Ingredients ......... Purpose

    70% Ethyl Alcohol (v/v)........ Antiseptic

    active

  • DO NOT USE

    Do not use in or near the eyes. In case of contact, rinse thoroughly with water.

    do not

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical attention or contact a poison center immediately.

    kids

  • PURPOSE

    USE

    Hand sanitizer to help reduce disease-causing bacteria

    use

  • STOP USE

    Stop use and ask a doctor if irriation or rash occurs.

    stop

  • WHEN USING

    Directions

    Apply liberally to dry hands, rub briskly until evaporated
    Children should be supervised when using this product

    when using

  • OTHER SAFETY INFORMATION

    OTHER INFORMATION

    Avoid freezing and excessive heat above 104F (40C)

    other

  • WARNINGS AND PRECAUTIONS

    WARNINGS

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

    Do not use in or near the eyes. In case of contact, rinse thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs.

    Keep out of reach of children. IF swallowed, get medical attention or contact a poison center immediately.

    warning

  • INSTRUCTIONS FOR USE

    DIRECTIONS

    Apply liberally to dry hands, rub briskly until evaporated.
    Children should be supervised when using this product

    instructions

  • INACTIVE INGREDIENT

    Aqua, Glycerine, Lavendula (Lavender) Essential Oil, Abies Siberica (Siberian Fir) Essential Oil

    inactive

  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    Apply liberally to dry hands, rub briskly until evaporated.
    Children should be supervised when using this product

    dosage

  • WARNINGS

    WARNINGS

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

    Do not use in or near the eyes. In case of contact, rinse thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs.

    Keep out of reach of children. IF swallowed, get medical attention or contact a poison center immediately.

    warnings

  • INDICATIONS & USAGE

    USE

    Hand sanitizer to help reduce disease-causing bacteria.

    indications

  • PRINCIPAL DISPLAY PANEL

    JENNI KAYNE | AMASS

    LAVENDER + FIR

    70% Alcohol-based hand sanitizer for when water is not available. Manufactured in Los Angeles, California. 16 oz | 473 mL -------------------------- Premium Botanics

    principal

  • INGREDIENTS AND APPEARANCE
    AMASS LAVENDER AND FIR HAND SANITIZER 
    lavender and fir hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77419-6001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL41.3 mL  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ABIES SIBIRICA LEAF OIL (UNII: XRY0V4VZKZ)  
    GLYCEROL FORMAL (UNII: 3L7GR2604E)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77419-6001-159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/13/2020
    2NDC:77419-6001-2473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/13/2020
    Labeler - AMASS Brands, Inc (121284034)
    Establishment
    NameAddressID/FEIBusiness Operations
    AMASS Brands, Inc121284034manufacture(77419-6001)