FDA.reportPublic FDA data

Hand sanitizer

Manufacturer
Genesis Salon Products LLC | Cospro Development Corp
Effective date
2020-05-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:13:41

Label at a glance#

ProductHand sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Put enough product in your palm to cover hands and rub hands together briskly until dry. Children under 6 years of age should be supervised when using this product.

Storage and handling

Store below 110F (43C)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) 
  2. Glycerol
  3. Sterile distilled water.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70%. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on skin. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from fire and flame

Do not use

OTC - DO NOT USE SECTION

  • Do not use in or near the eyes.

OTC - WHEN USING SECTION

When using this product do not use in or near the eyes. 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. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Put enough product in your palm to cover hands and rub hands together briskly until dry.
  • Children under 6 years of age should be supervised when using this product.

Other information

STORAGE AND HANDLING SECTION

  • Store below 110F (43C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, polysorbate 20, aloe barbadensis leaf juice, citrus aurantium dulcis (orange) peel oil, tocopheryl acetate, maltodextrin, purified water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76650-111-012022-01-28C16284748780-1d6a99b39-3d67-a426-e053-dadaa90af4c28dae07bd-1618-48ae-9923-9672bac1b834

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76650-111-01Hand sanitizer242 mL in 1 BOTTLESOLUTION2423

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76650-111HAND SANITIZER (ALCOHOL) SOLUTION [GENESIS SALON PRODUCTS LLC]3Legacy NDC, 1 package rows20200520_8dae07bd-1618-48ae-9923-9672bac1b834.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
76650-11176650-111-01

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
GLYCERINPDC6A3C0OXIACT
ORANGE PEELTI9T76XD44IACT
WATER059QF0KO0RIACT
ALOEV5VD430YW9IACT
MALTODEXTRIN7CVR7L4A2DIACT

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
063883bc-ba4e-4ecc-8621-6870c96c15cd8dae07bd-1618-48ae-9923-9672bac1b8342020-05-19WarningsExact identifier
spl id: 063883bc-ba4e-4ecc-8621-6870c96c15cd
spl set id: 8dae07bd-1618-48ae-9923-9672bac1b834

Reported adverse events (FAERS/openFDA)#

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