FDA.reportPublic FDA data

HAND SANITIZER GEL

Manufacturer
Sunshine Tape Products LLC
Effective date
2020-04-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:05:06

Label at a glance#

ProductHAND SANITIZER
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

Helps reduce bacteria on the skin. Recommended for repeated use.

Dosage and administration

Dispense enough product onto hands and rub together quickly until dry. Use as needed. Children under 6 years of age, use only under adult supervision.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

ETHYL ALCOHOL 62%

PURPOSE

OTC - PURPOSE SECTION

ANTISEPTIC

USES

INDICATIONS & USAGE SECTION

Helps reduce bacteria on the skin. Recommended for repeated use.

WARNINGS

WARNINGS SECTION

For external use only. Flammable. Keep away from fire or flame. When using this product avoid contact with eyes. In case of contact flush thoroughly with water. Avoid contact with open skin. Stop use and ask doctor if irritation or rash develops.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Dispense enough product onto hands and rub together quickly until dry. Use as needed. Children under 6 years of age, use only under adult supervision.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Purified water, Propylene Glycol, Glycerin, Carbomer, Triethanolamine, Tocopherol Acetate, Coconut Oil, Aloe Vera gel, Fragrance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Sunshine_Hand Sanitizer01b LBL_Sunshine_Hand Sanitizer

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN3
581660ethanol 0.62 ML/ML Topical GelSCD3
581660ethanol 62 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74598-111-112022-01-28C16284748780-1d6a99b39-54a4-a426-e053-dadaa90af4c2HAND SANITIZER GEL
74598-111-122022-01-28C16284748780-1d6a99b39-54a4-a426-e053-dadaa90af4c2HAND SANITIZER GEL
74598-111-142022-01-28C16284748780-1d6a99b39-54a4-a426-e053-dadaa90af4c2HAND SANITIZER GEL
74598-111-162022-01-28C16284748780-1d6a99b39-54a4-a426-e053-dadaa90af4c2HAND SANITIZER GEL
74598-111-182022-01-28C16284748780-1d6a99b39-54a4-a426-e053-dadaa90af4c2HAND SANITIZER GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74598-111-11HAND SANITIZER3785 mL in 1 JUGGEL37853
74598-111-12HAND SANITIZER59 mL in 1 BOTTLEGEL593
74598-111-14HAND SANITIZER118 mL in 1 BOTTLEGEL1183
74598-111-16HAND SANITIZER476 mL in 1 BOTTLEGEL4763
74598-111-18HAND SANITIZER238 mL in 1 BOTTLEGEL2383

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74598-111HAND SANITIZER (ETHYL ALCOHOL) GEL [SUNSHINE TAPE PRODUCTS LLC]3Legacy NDC, 5 package rows20200407_1f6f65e0-9f3e-45ff-a742-a90715f6ea93.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74598-11174598-111-18, 74598-111-14, 74598-111-16, 74598-111-11, 74598-111-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED)K6MOM3T5YLIACT
TROLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
COCONUT OILQ9L0O73W7LIACT

Source Document#

Source XML · Source PDF

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
7c14a8a6-d0ac-46a0-b6a2-399c62ac28061f6f65e0-9f3e-45ff-a742-a90715f6ea932020-04-03WarningsExact identifier
spl id: 7c14a8a6-d0ac-46a0-b6a2-399c62ac2806
spl set id: 1f6f65e0-9f3e-45ff-a742-a90715f6ea93

Reported adverse events (FAERS/openFDA)#

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