Label: AMASS BOTANICS HAND SANITIZER- amass botanics hand saniziter liquid

  • NDC Code(s): 77419-0001-1, 77419-0001-2, 77419-0001-3
  • Packager: AMASS Brands, Inc
  • 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 January 1, 2022

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  • Active Ingredients and back label

    Active Ingredients: 70% Ethyl Alcohol (v/v)

    Purpose: Antiseptic

    active ingredients

  • Warnings: Do Not Use

    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: Keep out of reach of children section

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

    Keep out of reach of children

  • Purpose / Use section

    USE

    Hand sanitizer to help reduce disease-causing bacteria.

    Use

  • Warnings: Stop Use when section

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

    Stop use

  • Directions when using

    DIRECTIONS

    Apply liberally to dry hands, rub briskly until evaporated.

    Children should be supervised when using this product.

    When using

  • Other Information

    OTHER INFORMATION

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

    Other information

  • 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

  • Directions

    DIRECTIONS

    Apply liberally to dry hands, rub briskly until evaporated.

    Children should be supervised when using this product.

    instructions

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

    Aloe Barbadensis Leaf Juice, Glycerin, Cinnamomum Verum (Cinnamon), Pimenta Diocia (Allspice), Syzygium Aromaticum (Clove), Eucalyptus Obliqua (Eucalyptus).

    inactive ingredients

  • 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 and 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 section

  • Use

    USE

    Hand sanitizer to help reduce disease-causing bacteria.

    Indications

  • PRINCIPAL DISPLAY PANEL

    [Brand Label: AMASS]

    Aloe

    Cinnamon

    Allspice

    Clove

    Eucalyptus

    70% Alcohol-based hand sanitizer for when water is unavailable. Apply liberally to dry hands and rub briskly until evaporated

    16 oz | 473 mL

    [Along side panel] ---------------- PREMIUM BOTANICS

    principal display panel

  • INGREDIENTS AND APPEARANCE
    AMASS BOTANICS HAND SANITIZER 
    amass botanics hand saniziter liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77419-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL331.223 mL  in 473.176 mL
    Inactive Ingredients
    Ingredient NameStrength
    ROSEMARY OIL (UNII: 8LGU7VM393) 0.199 mL  in 473.176 mL
    CLOVE OIL (UNII: 578389D6D0) 0.199 mL  in 473.176 mL
    EUCALYPTUS OIL (UNII: 2R04ONI662) 0.994 mL  in 473.176 mL
    LEMON OIL (UNII: I9GRO824LL) 0.0997 mL  in 473.176 mL
    ALLSPICE OIL (UNII: 032LND7FYA) 0.0997 mL  in 473.176 mL
    WATER (UNII: 059QF0KO0R) 118.294 mL  in 473.176 mL
    GLYCEROL FORMAL (UNII: 3L7GR2604E) 11.829 mL  in 473.176 mL
    CINNAMON OIL (UNII: E5GY4I6YCZ) 0.397 mL  in 473.176 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 9.842 mL  in 473.176 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77419-0001-2473.176 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/18/2020
    2NDC:77419-0001-159.147 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/05/2020
    3NDC:77419-0001-33785.41 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/05/2020
    Labeler - AMASS Brands, Inc (121284034)
    Establishment
    NameAddressID/FEIBusiness Operations
    JW Nutritional LLC017642837manufacture(77419-0001)
    Establishment
    NameAddressID/FEIBusiness Operations
    AMASS Brands, Inc121284034label(77419-0001)
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