Label: AMASS 4 THIEVES SANITIZER SERUM- 4 thieves serum 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 July 8, 2020

If you are a consumer or patient please visit this version.

  • Active Ingredients

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

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

    Active Ingredients

  • DO NOT USE

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

    do not use

  • KEEP OUT OF REACH OF CHILDREN

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

    keep out

  • 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 info

  • INSTRUCTIONS FOR USE

    DIRECTIONS

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

    directions

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Aqua, Vegetable Glycerin, Eucalyptus Obliqua (Eucalyptus) Oil, Salvia Rosmarinus (Rosemary) Oil, Syzygium Aromaticum (Clove) Oil, Cinnamomum Verum (Cinnamon) Oil, Lemon Oil, Pimenta Dioica (Allspice) Oil, Hydroxypropyl Cellulose, Lauryl Lactate, Myristyl Lactate, Cetyl Lactate

    inactive

  • 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

  • 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.

    warnings

  • INDICATIONS & USAGE

    USE

    Hand sanitizer to help reduce disease-causing bacteria.

    use

  • DOSAGE & ADMINISTRATION

    Directions

    Apply liberally to dry hands, rub briskly until evaporated.

    Children should be supervised when using this product.

    dosage

  • PRINCIPAL DISPLAY PANEL

    [sideways, to the left of body text] ---------------------PREMIUM BOTANICS

    [Brand Logo] AMASS

    [Product Name] FOUR THIEVES

    EUCALYPTUS

    ALLSPICE

    CLOVE

    CINNAMON

    70% Alcohol-based hand sanitizer for when water is unavailable. Manufactured in Los Angeles, California.

    16 OZ | 473 ML

    pdp

  • INGREDIENTS AND APPEARANCE
    AMASS 4 THIEVES SANITIZER SERUM 
    4 thieves serum gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77419-1000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL347.655 mL  in 473 mL
    Inactive Ingredients
    Ingredient NameStrength
    CINNAMON OIL (UNII: E5GY4I6YCZ) 0.4882580645 mL  in 473 mL
    CETYL LACTATE (UNII: A7EVH2RK4O) 1.576666666 mL  in 473 mL
    CLOVE OIL (UNII: 578389D6D0) 0.06103225806 mL  in 473 mL
    ROSEMARY OIL (UNII: 8LGU7VM393) 0.06103225806 mL  in 473 mL
    LAURYL LACTATE (UNII: G5SU0BFK7O) 1.576666667 mL  in 473 mL
    HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F) 2.365 mL  in 473 mL
    MYRISTYL LACTATE (UNII: 1D822OC34X) 1.576666667 mL  in 473 mL
    ALLSPICE OIL (UNII: 032LND7FYA) 0.2441290323 mL  in 473 mL
    LEMON OIL (UNII: I9GRO824LL) 0.2441290323 mL  in 473 mL
    WATER (UNII: 059QF0KO0R) 107.371 mL  in 473 mL
    EUCALYPTUS OIL (UNII: 2R04ONI662) 2.685419355 mL  in 473 mL
    GLYCEROL FORMAL (UNII: 3L7GR2604E) 7.095 mL  in 473 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77419-1000-1473 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/13/2020
    2NDC:77419-1000-23785.41 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/13/2020
    Labeler - AMASS Brands, Inc (121284034)
    Establishment
    NameAddressID/FEIBusiness Operations
    AMASS Brands, Inc121284034manufacture(77419-1000)