AMASS LEMON TISANE BOTANIC HAND SANITIZER- lemon tisane gel

AMASS Lemon Tisane Botanic Hand Sanitizer by

Drug Labeling and Warnings

AMASS Lemon Tisane Botanic Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by AMASS Brands, Inc, JW Nutritional LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

DO NOT USE

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

KEEP OUT OF REACH OF CHILDREN

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

PURPOSE

USE

Hand sanitizer to help reduce disease-causing bacteria

STOP USE

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

WHEN USING

Directions

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

OTHER SAFETY INFORMATION

OTHER INFORMATION

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

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.

INSTRUCTIONS FOR USE

DIRECTIONS

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

INACTIVE INGREDIENT

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

DOSAGE & ADMINISTRATION

DIRECTIONS

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

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.

INDICATIONS & USAGE

USE

Hand sanitizer to help reduce disease-causing bacteria.

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

INGREDIENTS AND APPEARANCE

AMASS LEMON TISANE BOTANIC HAND SANITIZER 
lemon tisane gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77419-4000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	2.781975 L  in 3.785 L

Inactive Ingredients
Ingredient Name	Strength
LAVENDER OIL (UNII: ZBP1YXW0H8)
CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)
WATER (UNII: 059QF0KO0R)
LAURYL LACTATE (UNII: G5SU0BFK7O)
LEMON OIL (UNII: I9GRO824LL)
GINGER OIL (UNII: SAS9Z1SVUK)
GRAPEFRUIT OIL (UNII: YR377U58W9)
SANDALWOOD OIL (UNII: X7X01WMQ5F)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)
CETYL LACTATE (UNII: A7EVH2RK4O)
MYRISTYL LACTATE (UNII: 1D822OC34X)
GLYCEROL FORMAL (UNII: 3L7GR2604E)
BENZYL BENZOATE (UNII: N863NB338G)
METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77419-4000-1	3.785 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/17/2020
2	NDC: 77419-4000-2	1.893 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/17/2020

Labeler - AMASS Brands, Inc (121284034)

Establishment
Name	Address	ID/FEI	Business Operations
JW Nutritional LLC		017642837	manufacture(77419-4000)

Establishment
Name	Address	ID/FEI	Business Operations
AMASS Brands, Inc		121284034	label(77419-4000)