FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
TRININE WELLNESS LLC
Effective date
2020-07-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:21:42

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product.

Storage and handling

Store below 106ºF. (41 ºC). May discolor certain fabrics or surfaces.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce germs on skin that could cause disease.

Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only: hands.Flammable. Keep away from heat, fire, or flame.

When using this product keep out of eyes, ears, and mouth. In case of contact

with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation, rash, or redness develops and lasts.

Keep out of reach for children. If swallowed, get medical help or contact a

Poison Control Center right away.

Do not use

OTC - DO NOT USE SECTION

/

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact

with eyes, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation, rash, or redness develops and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach for children. If swallowed, get medical help or contact a

Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product.

Other information

STORAGE AND HANDLING SECTION

Store below 106ºF. (41 ºC).

May discolor certain fabrics or surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Carbomer (Gel), Melaleuca Oil (Tea Tree Oil), Aloe Barbadensis Leaf Extract

(Aloe), Tocopherols (Vitamin E),Triethaolamine (Tea)

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79054-003-012021-07-23C16284748780-1c7ccaba7-1fb0-fd44-e053-dadaa90aa01bHand sanitizer
79054-003-022021-07-23C16284748780-1c7ccaba7-1fb0-fd44-e053-dadaa90aa01bHand sanitizer
79054-003-032021-07-23C16284748780-1c7ccaba7-1fb0-fd44-e053-dadaa90aa01bHand sanitizer
79054-003-042021-07-23C16284748780-1c7ccaba7-1fb0-fd44-e053-dadaa90aa01bHand sanitizer
79054-003-052021-07-23C16284748780-1c7ccaba7-1fb0-fd44-e053-dadaa90aa01bHand sanitizer
79054-003-062021-07-23C16284748780-1c7ccaba7-1fb0-fd44-e053-dadaa90aa01bHand sanitizer
79054-003-072021-07-23C16284748780-1c7ccaba7-1fb0-fd44-e053-dadaa90aa01bHand sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79054-003-01Hand Sanitizer50 mL in 1 BOTTLEGEL501
79054-003-02Hand Sanitizer60 mL in 1 BOTTLEGEL601
79054-003-03Hand Sanitizer120 mL in 1 BOTTLEGEL1201
79054-003-04Hand Sanitizer236 mL in 1 BOTTLEGEL2361
79054-003-05Hand Sanitizer500 mL in 1 BOTTLEGEL5001
79054-003-06Hand Sanitizer1000 mL in 1 BOTTLEGEL10001
79054-003-07Hand Sanitizer3785 mL in 1 BOTTLEGEL37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79054-003HAND SANITIZER GEL [TRININE WELLNESS LLC]1Legacy NDC, 7 package rows20200717_aa8c82d8-8836-e5d4-e053-2995a90abe92.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
79054-00379054-003-07, 79054-003-04, 79054-003-01, 79054-003-05, 79054-003-02, 79054-003-06, 79054-003-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TEA TREE OILVIF565UC2GIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
TROLAMINE9O3K93S3TKIACT
TOCOPHEROLR0ZB2556P8IACT
ALOE VERA LEAFZY81Z83H0XIACT

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
aa8c82d8-8835-e5d4-e053-2995a90abe92aa8c82d8-8836-e5d4-e053-2995a90abe922020-07-16WarningsExact identifier
spl id: aa8c82d8-8835-e5d4-e053-2995a90abe92
spl set id: aa8c82d8-8836-e5d4-e053-2995a90abe92