FDA.reportPublic FDA data

Grace and Stella Hand Sanitizer

Manufacturer
Grace & Stella Inc
Effective date
2020-04-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:09:16

Label at a glance#

ProductGrace and Stella Hand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Storage and handling

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

Label contents#

Full prescribing information#

Medicinal / Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 80%

Purpose

OTC - PURPOSE SECTION

Antiseptic

INACTIVE INGREDIENT SECTION

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

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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).

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Other information

STORAGE AND HANDLING SECTION

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 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN1
1039339ethanol 0.8 ML/ML Topical SolutionSCD1
1039339ethanol 80 % Topical SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76851-101-062022-01-28C16284748780-1d6a99b39-3be9-a426-e053-dadaa90af4c2grace & ​ stella HAND SANITIZER
76851-101-102022-01-28C16284748780-1d6a99b39-3be9-a426-e053-dadaa90af4c2grace & ​ stella HAND SANITIZER
76851-101-112022-01-28C16284748780-1d6a99b39-3be9-a426-e053-dadaa90af4c2grace & ​ stella HAND SANITIZER
76851-101-302022-01-28C16284748780-1d6a99b39-3be9-a426-e053-dadaa90af4c2grace & ​ stella HAND SANITIZER
76851-101-502022-01-28C16284748780-1d6a99b39-3be9-a426-e053-dadaa90af4c2grace & ​ stella HAND SANITIZER
76851-101-552022-01-28C16284748780-1d6a99b39-3be9-a426-e053-dadaa90af4c2grace & ​ stella HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76851-101-06Grace and Stella Hand Sanitizer60 mL in 1 BOTTLE, PLASTICLIQUID601
76851-101-10Grace and Stella Hand Sanitizer100 mL in 1 BOTTLE, PLASTICLIQUID1001
76851-101-11Grace and Stella Hand Sanitizer1000 mL in 1 BOTTLE, PUMPLIQUID10001
76851-101-30Grace and Stella Hand Sanitizer300 mL in 1 BOTTLE, PLASTICLIQUID3001
76851-101-50Grace and Stella Hand Sanitizer500 mL in 1 BOTTLE, PLASTICLIQUID5001
76851-101-55Grace and Stella Hand Sanitizer5000 mL in 1 CANLIQUID50001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76851-101GRACE AND STELLA HAND SANITIZER (ETHYL ALCOHOL) LIQUID [GRACE & STELLA INC]1Legacy NDC, 6 package rows20200502_88921a58-ccf5-41ef-9ee8-94150ea7b07b.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76851-10176851-101-06, 76851-101-10, 76851-101-30, 76851-101-50, 76851-101-11, 76851-101-55

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT

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
dbc3c01b-973f-473e-944b-ce4ce00af32788921a58-ccf5-41ef-9ee8-94150ea7b07b2020-04-29WarningsExact identifier
spl id: dbc3c01b-973f-473e-944b-ce4ce00af327
spl set id: 88921a58-ccf5-41ef-9ee8-94150ea7b07b

Reported adverse events (FAERS/openFDA)#

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