FDA.reportPublic FDA data

Shelter Point Sanitizer

Manufacturer
Shelter Point Distillery Corporation
Effective date
2020-04-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:17:00

Label at a glance#

ProductShelter Point Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

hand sanitizer to decrease bacteria on the skin recommended for repeated use for use when soap and water are not available

Dosage and administration

wet hands thoroughly with product and allow to dry without wiping supervise children 6 years of age when using this product to avoid swallowing

Storage and handling

store between 15-30°C (59-86°F) avoid freezing and excessive heat above 40°C (104°F) do not use if tamper seal is broken

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • hand sanitizer to decrease bacteria on the skin
  • recommended for repeated use
  • for use when soap and water are not available

Warnings

WARNINGS SECTION

Flammable, keep away from fire/flame

For external use only

Do not use 

  • in children less than 2 months of age
  • on open skin wounds

When using this product  •  do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if 

  • irritation and redness develop
  • condition persists more for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • wet hands thoroughly with product and allow to dry without wiping
  • supervise children 6 years of age when using this product to avoid swallowing

Other information

STORAGE AND HANDLING SECTION

  • store between 15-30°C (59-86°F)
  • avoid freezing and excessive heat above 40°C (104°F)
  • do not use if tamper seal is broken

INACTIVE INGREDIENT SECTION

Inactive ingredients  glycerin, hydrogen peroxide, water

OTC - QUESTIONS SECTION

Questions? +1-778-420-2200

You may also report serious side effects to this phone number.

Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

NOT FOR CONSUMPTION 

75% alc./vol.

MADE IN CANADA

Manufactured by:

SHELTER POINT DISTILLERY

4650 Regent Rd. Campbell River. BC. CA. V9H 1E3

COUNTRY OF ORIGIN: CANADA

PH. 1 778 420 2200 |  www.shelterpont.ca

Expiry: June 10 2022

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2286295ethanol 75 % Topical SprayPSN1
2286295ethanol 0.75 ML/ML Topical SpraySCD1
2286295ethanol 75 % Topical SpraySY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76601-101-102021-07-23C16284748780-1c7ccaba7-2268-fd44-e053-dadaa90aa01bSHELTER POINT DISTILLERY ANTISEPTIC PURPOSE SANITIZER
76601-101-202021-07-23C16284748780-1c7ccaba7-2268-fd44-e053-dadaa90aa01bSHELTER POINT DISTILLERY ANTISEPTIC PURPOSE SANITIZER
76601-101-752021-07-23C16284748780-1c7ccaba7-2268-fd44-e053-dadaa90aa01bSHELTER POINT DISTILLERY ANTISEPTIC PURPOSE SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76601-101-10Shelter Point Sanitizer10 L in 1 CONTAINERSPRAY101
76601-101-20Shelter Point Sanitizer20 L in 1 CONTAINERSPRAY201
76601-101-75Shelter Point Sanitizer0.75 L in 1 BOTTLE, PLASTICSPRAY0.751

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76601-101SHELTER POINT SANITIZER (ETHYL ALCOHOL) SPRAY [SHELTER POINT DISTILLERY CORPORATION]1Legacy NDC, 3 package rows20200611_1175243c-28ef-486f-a838-921901bde61a.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
76601-10176601-101-75, 76601-101-10, 76601-101-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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

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
e85b7030-1018-4abe-ab2f-de36204af7091175243c-28ef-486f-a838-921901bde61a2020-04-29WarningsExact identifier
spl id: e85b7030-1018-4abe-ab2f-de36204af709
spl set id: 1175243c-28ef-486f-a838-921901bde61a

Reported adverse events (FAERS/openFDA)#

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