FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
GOOSE CREEK CANDLES, LLC | Oxygen Development LLC
Effective date
2022-03-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:48:38

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

Put enough product in your palm to cover hands & rub hands together until dry. Children under 6 years of age should be supervised when using this product

Storage and handling

store below 110 F (43 C). May discolor certain fabric surfaces.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

OTC - WHEN USING SECTION

For handwashing to decrease bacteria on the skin.

Warnings

WARNINGS SECTION

Do not eat or drink. Topical application only. Flammable. Keep away from fire or flame. For external use only.

When using this product

INDICATIONS & USAGE SECTION

When using this product do not use in or near the eyes. in case of contact, rinse eyes troroughly with water.

Stop use and ask doctor

OTC - STOP USE SECTION

Stop use and ask doctor if irritation or rash persists.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Put enough product in your palm to cover hands & rub hands together until dry. Children under 6 years of age should be supervised when using this product

Other Information

STORAGE AND HANDLING SECTION

store below 110 F (43 C). May discolor certain fabric surfaces.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua, Glycerin, Fragrance, Polysorbate 20, Carbomer, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82463-036-01_aw82463-036-01_aw61354-036-01_AW61354-036-01_AW

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82463-036-012025-01-30C16284748780-12cef2736-a90f-d83d-e063-dadaa90ab31fGel Hand Sanitizer with aloe. Moisturizes & hydrates Skin 70% Alcohol. Tropical Daydream.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82463-036-01Hand Sanitizer100 mL in 1 BOTTLELIQUID1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82463-036HAND SANITIZER (ALCOHOL) LIQUID [GOOSE CREEK CANDLES, LLC]2Legacy NDC, 1 package rows20220308_d9a3893b-60f7-8ead-e053-2995a90a4cba.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
82463-03682463-036-01

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
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
FRAGRANCE 135765EM498GW35IACT
POLYSORBATE 207T1F30V5YHIACT

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
d9a3893b-60f6-8ead-e053-2995a90a4cbad9a3893b-60f7-8ead-e053-2995a90a4cba2022-03-07WarningsExact identifier
spl id: d9a3893b-60f6-8ead-e053-2995a90a4cba
spl set id: d9a3893b-60f7-8ead-e053-2995a90a4cba

Reported adverse events (FAERS/openFDA)#

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