GRACE AND STELLA HAND SANITIZER- ethyl alcohol liquid 
Grace & Stella Inc

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.

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grace &​ stella HAND SANITIZER

Drug Facts

Medicinal / Active Ingredient

Ethyl alcohol 80%

Purpose

Antiseptic

Non medicinal / Inactive ingredients: Water (aqua), Glycerin, Hydrogen Peroxide, Denatonim Benzoate

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

Directions: Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry. Children under 6 years of age should be supervised when using this product. Use as part of your daily cleansing routine. For occasional and personal domestic use.

Dosage: Applied as needed

Warnings: For external use only.

Stop use and ask/ consult a doctor/ physician / health care practitioner / health care provider / health care professional if irritation develops.

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Do not use on open skin wounds.

Contraindications: Do not use on children/infants less than 2 years of age (unless directed by a doctor / physician / health care practitioner / health care provider / health care professional).

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

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.

Topical & Non-Sterile Solution

@GRACEANDSTELLA

GRACEANDSTELLA.COM

KILLS MOST 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 P.R.C.

EXPIRY: 05/30/2023

Packaging

IMAGE

GRACE AND STELLA HAND SANITIZER 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76851-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76851-101-0660 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/29/2020
2NDC:76851-101-10100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/29/2020
3NDC:76851-101-30300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/29/2020
4NDC:76851-101-50500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/29/2020
5NDC:76851-101-111000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/29/2020
6NDC:76851-101-555000 mL in 1 CAN; Type 0: Not a Combination Product04/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/29/2020
Labeler - Grace & Stella Inc (204270191)

Revised: 4/2020
Document Id: dbc3c01b-973f-473e-944b-ce4ce00af327
Set id: 88921a58-ccf5-41ef-9ee8-94150ea7b07b
Version: 1
Effective Time: 20200429
 
Grace & Stella Inc