FDA.reportPublic FDA data

GRACE AND STELLA HAND SANITIZER

Manufacturer
Grace & Stella Inc
Effective date
2020-05-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:18:21

Label at a glance#

ProductGRACE AND STELLA HAND SANITIZER
Active ingredientALCOHOL
Label structure9 sections

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.

Label contents#

Full prescribing information#

Medicinal Ingredient (v/v):

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antiseptic

INACTIVE INGREDIENT SECTION

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

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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.

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.

STORAGE AND HANDLING SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Grce1Grce1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1305100ethanol 75 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76851-102-062022-01-28C16284748780-1d6a99b39-dc18-a426-e053-dadaa90af4c2grace & stella HAND SANITIZER
76851-102-102022-01-28C16284748780-1d6a99b39-dc18-a426-e053-dadaa90af4c2grace & stella HAND SANITIZER
76851-102-112022-01-28C16284748780-1d6a99b39-dc18-a426-e053-dadaa90af4c2grace & stella HAND SANITIZER
76851-102-302022-01-28C16284748780-1d6a99b39-dc18-a426-e053-dadaa90af4c2grace & stella HAND SANITIZER
76851-102-502022-01-28C16284748780-1d6a99b39-dc18-a426-e053-dadaa90af4c2grace & stella HAND SANITIZER
76851-102-552022-01-28C16284748780-1d6a99b39-dc18-a426-e053-dadaa90af4c2grace & stella HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76851-102-06GRACE AND STELLA HAND SANITIZER60 mL in 1 BOTTLE, PLASTICGEL601
76851-102-10GRACE AND STELLA HAND SANITIZER100 mL in 1 BOTTLE, PLASTICGEL1001
76851-102-11GRACE AND STELLA HAND SANITIZER1000 mL in 1 BOTTLE, PUMPGEL10001
76851-102-30GRACE AND STELLA HAND SANITIZER300 mL in 1 BOTTLE, PLASTICGEL3001
76851-102-50GRACE AND STELLA HAND SANITIZER500 mL in 1 BOTTLE, PLASTICGEL5001
76851-102-55GRACE AND STELLA HAND SANITIZER5000 mL in 1 CANGEL50001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76851-102GRACE AND STELLA HAND SANITIZER (ETHYL ALCOHOL) GEL [GRACE & STELLA INC]1Legacy NDC, 6 package rows20200619_becbd668-5b41-4eee-8bc3-43968b6f79f1.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76851-10276851-102-06, 76851-102-10, 76851-102-30, 76851-102-50, 76851-102-11, 76851-102-55

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
SODIUM BICARBONATE8MDF5V39QOIACT
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
b19dffd0-4448-4a22-94c3-2ced095222ddbecbd668-5b41-4eee-8bc3-43968b6f79f12020-05-06WarningsExact identifier
spl id: b19dffd0-4448-4a22-94c3-2ced095222dd
spl set id: becbd668-5b41-4eee-8bc3-43968b6f79f1

Reported adverse events (FAERS/openFDA)#

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