GRACE AND STELLA HAND SANITIZER- ethyl alcohol gel

GRACE AND STELLA HAND SANITIZER by

Drug Labeling and Warnings

GRACE AND STELLA HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Grace & Stella Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Product Facts

Medicinal Ingredient (v/v):

Ethyl alcohol 75%

Purpose

Antiseptic

INACTIVE INGREDIENT

Non-medicinal ingredients: Water (aqua), Carbomer, Glycerin, Sodium Bicarbonate, Denatonium Benzoate.

INDICATIONS & USAGE

Uses: For personal hand hygiene to help prevent the spread of bacteria.

DOSAGE & ADMINISTRATION

Directions: For occasional personal and domestic use. Place a dime sized drop of product in your palm. Rub thoroughly into hands for at least 30 seconds. Allow to dry. Supervise children when they use this product.

Dosage: Apply as needed.

WARNINGS

Warnings: For external use only.

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and consult a health care professional if irritation develops.

Flammability Warning: Keep away from open flame and sources of heat.​

Security Feature: If the security foil under the cap is missing or damaged do not use the product.

Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away.

STORAGE AND HANDLING

Other information: Store between 15-30°C (59-86°F). Avoid freezing and excessive heat above 40°C (104°F). May discolour certain fabrics or surfaces.

SPL UNCLASSIFIED SECTION

Topical & Non-Sterile Gel

75% Ethyl Alcohol

KILLS HARMFUL GERMS

Imported by: Grace & Stella Inc.

320 - 425 Carrall St.

Vancouver, BC, V6B 6E3, Canada

Questions?? Call toll free

1-877-30-PAMPER (1-877-307-2673)

info@graceandstella.com

www.graceandstella.com

MADE IN CHINA

@GRACEANDSTELLA

GRACEANDSTELLA.COM

Packaging

INGREDIENTS AND APPEARANCE

GRACE AND STELLA HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76851-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76851-102-06	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/06/2020
2	NDC: 76851-102-10	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/06/2020
3	NDC: 76851-102-30	300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/06/2020
4	NDC: 76851-102-50	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/06/2020
5	NDC: 76851-102-11	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/06/2020
6	NDC: 76851-102-55	5000 mL in 1 CAN; Type 0: Not a Combination Product	05/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/06/2020

Labeler - Grace & Stella Inc (204270191)