FDA.reportPublic FDA data

Happy Hands Hand Sanitizer

Manufacturer
True Chemical Solutions, LLC
Effective date
2021-01-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:36:42

Label at a glance#

ProductHappy Hands Hand 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 to avoid swallowing.

Label contents#

Full prescribing information#

Active ingredient[s]

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use[s]

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash occurs. These may be signs of a serious condition.

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

• 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 to avoid swallowing.

Other information

SPL UNCLASSIFIED SECTION

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Carbomer, Glycerin, Triethanolamine, Iodopropynyl Butylcarbamate, Methylisothiazolinone

Package Labeling:118ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Package Labeling:473ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bottle 2bottle 2Label2Label2

Package Labeling:946.34ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle3Bottle3

Package Labeling:1.8927L

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle4Bottle4

Package Labeling:2000ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle5Bottle5

Package Labeling:3.785L

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle6Bottle6

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77991-004-012022-07-29C16284748780-1e4f33bdf-9ca5-d8a0-e053-dadaa90a6e4eHappy Hands Hand Sanitizer
77991-004-022022-07-29C16284748780-1e4f33bdf-9ca5-d8a0-e053-dadaa90a6e4eHappy Hands Hand Sanitizer
77991-004-032022-07-29C16284748780-1e4f33bdf-9ca5-d8a0-e053-dadaa90a6e4eHappy Hands Hand Sanitizer
77991-004-042022-07-29C16284748780-1e4f33bdf-9ca5-d8a0-e053-dadaa90a6e4eHappy Hands Hand Sanitizer
77991-004-052022-07-29C16284748780-1e4f33bdf-9ca5-d8a0-e053-dadaa90a6e4eHappy Hands Hand Sanitizer
77991-004-062022-07-29C16284748780-1e4f33bdf-9ca5-d8a0-e053-dadaa90a6e4eHappy Hands Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77991-004-01Happy Hands Hand Sanitizer118 mL in 1 BOTTLEGEL1181
77991-004-02Happy Hands Hand Sanitizer473 mL in 1 BOTTLEGEL4731
77991-004-03Happy Hands Hand Sanitizer946.34 mL in 1 BOTTLEGEL946.341
77991-004-04Happy Hands Hand Sanitizer1892.7 mL in 1 BOTTLEGEL1892.71
77991-004-05Happy Hands Hand Sanitizer2000 mL in 1 BOTTLEGEL20001
77991-004-06Happy Hands Hand Sanitizer3785 mL in 1 BOTTLEGEL37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77991-004HAPPY HANDS HAND SANITIZER (ALCOHOL) GEL [TRUE CHEMICAL SOLUTIONS, LLC]1Legacy NDC, 6 package rows20210109_b8679ba2-d66d-3e96-e053-2995a90a3186.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
77991-00477991-004-01, 77991-004-02, 77991-004-03, 77991-004-04, 77991-004-05, 77991-004-06

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
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
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
b8677ec0-997e-c475-e053-2a95a90ad198b8679ba2-d66d-3e96-e053-2995a90a31862021-01-08WarningsExact identifier
spl id: b8677ec0-997e-c475-e053-2a95a90ad198
spl set id: b8679ba2-d66d-3e96-e053-2995a90a3186

Reported adverse events (FAERS/openFDA)#

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