FDA.reportPublic FDA data

Hiddenorga Hand Sanitizer

Manufacturer
Hiddenorga
Effective date
2020-04-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:08:11

Label at a glance#

ProductHiddenorga Hand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

Uses: Hand sanitizer to help reduce bacteria that potentially can cause disease.

Dosage and administration

Directions: • 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

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: Ethanol 70% v/v

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients:

Melaleuca Alternifolia (Tea Tree) Leaf Extract, Glycerin, Hyaluronic Acid, Rosmarinus Officinalis (Rosemary) Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil

PURPOSE

OTC - PURPOSE SECTION

Purpose: ANTISEPTIC

WARNINGS

WARNINGS SECTION

Warnings:

For external use only. Flammable. Keep away from heat or flame
--------------------------------------------------------------------------------------------------------
Do not use
• in children less than 2 months of age
• on open skin wounds
--------------------------------------------------------------------------------------------------------
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 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

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

Uses

INDICATIONS & USAGE SECTION

Uses:

Hand sanitizer to help reduce bacteria that potentially can cause disease.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions:

• 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

OTHER SAFETY INFORMATION

Other information

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

Package Label : Hiddenorga Hand Sanitizer (500mL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottleImage of bottle

Package Label : Hiddenorga Hand Sanitizer (1000mL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottleImage of bottle

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
76765-020-012022-01-28C16284748780-1d6a99b39-a433-a426-e053-dadaa90af4c22f21c8cd-b8fc-4715-9d55-653eff4e5bf0
76765-020-022022-01-28C16284748780-1d6a99b39-a433-a426-e053-dadaa90af4c22f21c8cd-b8fc-4715-9d55-653eff4e5bf0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76765-020-01Hiddenorga Hand Sanitizer500 mL in 1 BOTTLE, PUMPGEL5001
76765-020-02Hiddenorga Hand Sanitizer1000 mL in 1 BOTTLE, PUMPGEL10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76765-020HIDDENORGA HAND SANITIZER (ALCOHOL) GEL [HIDDENORGA]1Legacy NDC, 2 package rows20200428_2f21c8cd-b8fc-4715-9d55-653eff4e5bf0.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
76765-02076765-020-01, 76765-020-02

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
ALCOHOL3K9958V90MACTIB
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
GlycerinPDC6A3C0OXIACT
HYALURONIC ACIDS270N0TRQYIACT
ROSEMARYIJ67X351P9IACT
TEA TREE OILVIF565UC2GIACT

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
4edcab14-beae-4d49-a18a-88132ea63a6d2f21c8cd-b8fc-4715-9d55-653eff4e5bf02020-04-28WarningsExact identifier
spl id: 4edcab14-beae-4d49-a18a-88132ea63a6d
spl set id: 2f21c8cd-b8fc-4715-9d55-653eff4e5bf0

Reported adverse events (FAERS/openFDA)#

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