FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Audy Global Enterprises Inc. | Zhongrong Technology Corporation Ltd.
Effective date
2021-10-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:44:28

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

Place enough product in your palm to thoroughly cover your hands Children under 6 years of age should be supervised when using this product Rub hands together briskly until dry

Storage and handling

Protect the product in this container from excessive heat and direct sun. Store below 104°F (40°C) May discolor certain fabrics.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 67%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria on the skin. Recommended for repeated use.

Warnings

WARNINGS SECTION

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

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.

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 redness develop.

If condition persists for more than 72 hours.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product in your palm to thoroughly cover your hands
  • Children under 6 years of age should be supervised when using this product
  • Rub hands together briskly until dry

Other information

STORAGE AND HANDLING SECTION

  • Protect the product in this container

from excessive heat and direct sun.

  • Store below 104°F (40°C)
  • May discolor certain fabrics.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Aloe Barbadensis Leaf Juice, Radish Root Ferment Filtrate, Fragrance (parfum), Glycereth-26, Lime (Citrus Aurantifolia) Seed Oil, Lemon (Citrus Limon) Peel Oil, FD&C Red No. 40, FD&C Yellow No. 5, Limonene, Citral, Citronellol, Linalool

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package combination of 3 bottles, each bottle contains 45 mL NDC: 75778-006-30 75778-006-01_3-bottle combination package_45 mL75778-006-01_3-bottle combination package_45 mL

Bottle 1 of 3, Water Melon scent 45 mL NDC: 75778-006-30 75778-006-01_Water Melon scent bottle 45 mL75778-006-01_Water Melon scent bottle 45 mL

Bottle 2 of 3, Citrus scent 45 mL NDC: 75778-006-30 75778-006-01_Citrus scent bottle 45 mL75778-006-01_Citrus scent bottle 45 mL

Bottle 3 of 3, Vanilla Cinnamon scent 45 mL NDC: 75778-006-30 75778-006-01_Vanilla Cinnamon scent bottle 45 mL75778-006-01_Vanilla Cinnamon scent bottle 45 mL

Package combination of 3 bottles, each bottle contains 45 mL NDC: 75778-006-31 75778-006-02_3-bottle combination package_45 mL75778-006-02_3-bottle combination package_45 mL

Bottle 1 of 3, Lavender scent 45 mL NDC: 75778-006-31 75778-006-02_Lavender scent bottle 45 mL75778-006-02_Lavender scent bottle 45 mL

Bottle 2 of 3, Mint scent 45 mL NDC: 75778-006-31 75778-006-02_Mint scent bottle 45 mL75778-006-02_Mint scent bottle 45 mL

Bottle 3 of 3, Aloe Vera scent 45 mL NDC: 75778-006-31 75778-006-31_Aloe Vera scent bottle 45 mL75778-006-31_Aloe Vera scent bottle 45 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039708ethanol 67 % Topical GelPSN2
1039708ethanol 0.67 ML/ML Topical GelSCD2
1039708ethanol 67 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75778-006-302023-01-30C16284748780-1f386c64a-3e20-0266-e053-dadaa90a7c1aSimply Natural Hand Sanitizer
75778-006-312023-01-30C16284748780-1f386c64a-3e20-0266-e053-dadaa90a7c1aSimply Natural Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75778-006-30Hand Sanitizer3 in 1 PACKAGEGEL32
75778-006-30Hand Sanitizer1 in 1 PACKAGE, COMBINATIONGEL12
75778-006-31Hand Sanitizer1 in 1 PACKAGE, COMBINATIONGEL12
75778-006-31Hand Sanitizer3 in 1 PACKAGEGEL32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75778-006HAND SANITIZER (ALCOHOL) GEL [AUDY GLOBAL ENTERPRISES INC.]2Legacy NDC, 4 package rows20211027_c24d7bef-39c2-6dae-e053-2995a90a297f.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75778-00675778-006-30, 75778-006-31

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIMONENE, (+)-GFD7C86Q1WIACT
ALOE VERA LEAFZY81Z83H0XIACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
CITRUS AURANTIFOLIA SEED OILEW089HAI77IACT
LEMON OIL, TERPENELESSX69W83NI7VIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERETH-26NNE56F2N14IACT
FD&C YELLOW NO. 5I753WB2F1MIACT
CITRALT7EU0O9VPPIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
LINALOOL, (+/-)-D81QY6I88EIACT

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
cf336778-6cfe-5fbc-e053-2995a90ad277c24d7bef-39c2-6dae-e053-2995a90a297f2021-10-25WarningsExact identifier
spl id: cf336778-6cfe-5fbc-e053-2995a90ad277
spl set id: c24d7bef-39c2-6dae-e053-2995a90a297f

Reported adverse events (FAERS/openFDA)#

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