FDA.reportPublic FDA data

Maple Cross Hand Sanitizer

Manufacturer
Maple Cross Health Inc.
Effective date
2020-06-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:21:20

Label at a glance#

ProductMaple Cross Hand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Dosage and administration

Rub thoroughly into hands for at least 30 seconds. Allow to dry. For occasional and personal domestic use. Supervise children when they use this product.

Label contents#

Full prescribing information#

Medicinal / Active ingredient:

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 75% v/v

Purpose:

OTC - PURPOSE SECTION

Antiseptic

Non medicinal / Inactive ingredients:

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycerin, Polyacrylic Acid,Sodium Bicarbonate, Denatonium benzoate. This product does not contain mercury.

Indications:

INDICATIONS & USAGE SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

Rub thoroughly into hands for at least 30 seconds. Allow to dry. For occasional and personal domestic use. Supervise children when they use this product.

Warning:

WARNINGS SECTION

Flammability warning. Keep away from open flame and sources of heat. For external use only.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, call a poison control centre or get medical help right away.

Stop use and ask/ consult a doctor/ physician/ health care practitioner/ health care rovider/ health care professional

OTC - STOP USE SECTION

if irritation develops.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Contraindications:

CONTRAINDICATIONS SECTION

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).

Other information:

SPL UNCLASSIFIED SECTION

Store below 110°F (43°C). May discolour certain fabrics or surfaces.

Package labeling: 300ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label1Label1

Package labeling: 500ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Package labeling: 1000ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

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
77216-001-002022-01-28C16284748780-1d6a99b39-c270-a426-e053-dadaa90af4c2Maple Cross Hand Sanitizer
77216-001-012022-01-28C16284748780-1d6a99b39-c270-a426-e053-dadaa90af4c2Maple Cross Hand Sanitizer
77216-001-022022-01-28C16284748780-1d6a99b39-c270-a426-e053-dadaa90af4c2Maple Cross Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77216-001-00Maple Cross Hand Sanitizer300 mL in 1 BOTTLEGEL3001
77216-001-01Maple Cross Hand Sanitizer500 mL in 1 BOTTLEGEL5001
77216-001-02Maple Cross Hand Sanitizer1000 mL in 1 BOTTLEGEL10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77216-001MAPLE CROSS HAND SANITIZER (ALCOHOL) GEL [MAPLE CROSS HEALTH INC.]1Legacy NDC, 3 package rows20200715_a7979068-d388-6dd4-e053-2a95a90afb92.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77216-00177216-001-00, 77216-001-01, 77216-001-02

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
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SODIUM BICARBONATE8MDF5V39QOIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
ALCOHOL3K9958V90MACTIB

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
a797a150-2048-6de8-e053-2995a90a7675a7979068-d388-6dd4-e053-2a95a90afb922020-06-08WarningsExact identifier
spl id: a797a150-2048-6de8-e053-2995a90a7675
spl set id: a7979068-d388-6dd4-e053-2a95a90afb92

Reported adverse events (FAERS/openFDA)#

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