FDA.reportPublic FDA data

Inpure hand sanitizer

Manufacturer
YEGREENA CO., LTD.
Effective date
2020-06-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:16:07

Label at a glance#

ProductInpure hand sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

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

Storage and handling

Store between 15-30C (59-86F) May discolor certain fabrics or surfaces.

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) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

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

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.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts.

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

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Citrus Limon (Lemon) Fruit Extract, Carbomer, Glycerin, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Citrus Paradisi Seed, Camellia Sinensis Leaf Extract, Sodium Hyaluronate

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • May discolor certain fabrics or surfaces.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500mL Label500mL Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041498ethanol 80 % Topical GelPSN2
1041498ethanol 0.8 ML/ML Topical GelSCD2
1041498ethanol 80 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78417-101-102022-01-28C16284748780-1d6a99b39-59f4-a426-e053-dadaa90af4c2a6b310ed-bf40-f4d3-e053-2995a90a08f3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78417-101-10Inpure hand sanitizer500 mL in 1 BOTTLE, PUMPGEL5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78417-101INPURE HAND SANITIZER (HAND SANITIZER) GEL [YEGREENA CO., LTD.]2Legacy NDC, 1 package rows20200605_a6b310ed-bf40-f4d3-e053-2995a90a08f3.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78417-10178417-101-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31IACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
LEMON OILI9GRO824LLIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
HYALURONATE SODIUMYSE9PPT4THIACT
ALOE VERA LEAFZY81Z83H0XIACT
CITRUS PARADISI SEED12F08874Y7IACT
GREEN TEA LEAFW2ZU1RY8B0IACT

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
a73f023e-941f-9fc0-e053-2995a90abcbea6b310ed-bf40-f4d3-e053-2995a90a08f32020-06-04WarningsExact identifier
spl id: a73f023e-941f-9fc0-e053-2995a90abcbe
spl set id: a6b310ed-bf40-f4d3-e053-2995a90a08f3

Reported adverse events (FAERS/openFDA)#

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