FDA.reportPublic FDA data

AMASS Lemon Tisane Botanic Hand Sanitizer

Manufacturer
AMASS Brands, Inc | JW Nutritional LLC
Effective date
2022-01-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:49:14

Label at a glance#

ProductAMASS Lemon Tisane Botanic Hand Sanitizer
Active ingredientALCOHOL
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

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

activeactive

OTC - DO NOT USE SECTION

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

do notdo not

OTC - 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'keep'

OTC - PURPOSE SECTION

USE

Hand sanitizer to help reduce disease-causing bacteria

purposepurpose

OTC - STOP USE SECTION

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

stopstop

OTC - WHEN USING SECTION

Directions

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

when usingwhen using

OTHER SAFETY INFORMATION

OTHER INFORMATION

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

other safetyother safety

WARNINGS AND PRECAUTIONS SECTION

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 andwarnings and

INSTRUCTIONS FOR USE SECTION

DIRECTIONS

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

instructionsinstructions

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS

Aqua, Glycerine, Lemon Oil, Zingiber Officinale (Ginger) Oil, Citrus Paradisi (Grapefruit) Oil, Cedarwood Oil, Sandalwood Oil, Lavandula (Lavender) Oil, Fragrance, Hydroxypropyl Cellulose, Lauryl Lactate, Myristyl Lactate, Cetyl Lactate

inactiveinactive

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS

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

dosagedosage

WARNINGS SECTION

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.

warningswarnings

INDICATIONS & USAGE SECTION

USE

Hand sanitizer to help reduce disease-causing bacteria.

indicationsindications

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

B+N logo
AMASS logo

LEMON TISANE

LEMON
GINGER
GRAPEFRUIT
CEDARWOOD

70% Alcohol-based hand sanitizer for when water is not available. Manufactured in Los Angeles, California.

1 gal | 3.785 l

---------------------------- Premium Botanics

PRINCIPALPRINCIPAL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77419-4000-12024-01-30C16284748780-1d6a99b39-e08a-a426-e053-dadaa90af4c2ad08d675-7473-ca54-e053-2a95a90a5de4
77419-4000-22024-01-30C16284748780-1d6a99b39-e08a-a426-e053-dadaa90af4c2ad08d675-7473-ca54-e053-2a95a90a5de4
77419-4000-12022-04-18C16284748780-1d6a99b39-e08a-a426-e053-dadaa90af4c2ad08d675-7473-ca54-e053-2a95a90a5de4
77419-4000-12022-01-28C16284748780-1d6a99b39-e08a-a426-e053-dadaa90af4c2ad08d675-7473-ca54-e053-2a95a90a5de4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77419-4000-1AMASS Lemon Tisane Botanic Hand Sanitizer3.785 L in 1 BOTTLE, PUMPGEL3.7852
77419-4000-2AMASS Lemon Tisane Botanic Hand Sanitizer1.893 L in 1 BOTTLE, PUMPGEL1.8932

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77419-4000AMASS LEMON TISANE BOTANIC HAND SANITIZER (LEMON TISANE) GEL [AMASS BRANDS, INC]2Legacy NDC, 2 package rows20220418_ad08d675-7473-ca54-e053-2a95a90a5de4.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77419-400077419-4000-1, 77419-4000-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
LAVENDER OILZBP1YXW0H8IACT
CEDRUS ATLANTICA BARK OILZX5QRE4U60IACT
WATER059QF0KO0RIACT
LAURYL LACTATEG5SU0BFK7OIACT
LEMON OILI9GRO824LLIACT
GINGER OILSAS9Z1SVUKIACT
GRAPEFRUIT OILYR377U58W9IACT
SANDALWOOD OILX7X01WMQ5FIACT
LIMONENE, (+)-GFD7C86Q1WIACT
ALCOHOL3K9958V90MACTIB
HYDROXYPROPYL CELLULOSE (90000 WAMW)UKE75GEA7FIACT
CETYL LACTATEA7EVH2RK4OIACT
MYRISTYL LACTATE1D822OC34XIACT
GLYCEROL FORMAL3L7GR2604EIACT
BENZYL BENZOATEN863NB338GIACT
METHYL DIHYDROJASMONATE (SYNTHETIC)3GW44CIE3YIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d83eb4b5-e584-2d26-e053-2a95a90ae274ad08d675-7473-ca54-e053-2a95a90a5de42022-01-01WarningsExact identifier
spl id: d83eb4b5-e584-2d26-e053-2a95a90ae274
spl set id: ad08d675-7473-ca54-e053-2a95a90a5de4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.