FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
DVRYL International Limited
Effective date
2020-07-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:23:18

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

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

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Flammable, keep away from fire or flame

For external use only.

Do not use

OTC - DO NOT USE SECTION

in the eyes.

Stop use and ask a doctor if 

OTC - STOP USE SECTION

  • irritation and redness develop 
  • condition persists for more than 72 hours

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

  • Wet hands thoroughly with product and allow to dry without wiping.

Other information

SPL UNCLASSIFIED SECTION

Store at 15° to 25°C (59° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, propylene glycol, purified water, titanium dioxide

OTC - QUESTIONS SECTION

TO REPOT ADVERSE EVENT, CONTACT +1(727)441-3222

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottleBoxBox

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
78894-000-062022-01-28C16284748780-1d6a99b39-5e3f-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78894-000-06Hand Sanitizer1 in 1 BOXGEL11
78894-000-06Hand Sanitizer200 mL in 1 BOTTLEGEL2001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78894-000HAND SANITIZER (ALCOHOL) GEL [DVRYL INTERNATIONAL LIMITED]1Legacy NDC, 2 package rows20200731_abad9d47-78cc-0fcf-e053-2a95a90ad6a4.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78894-00078894-000-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
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
abad9d47-78cd-0fcf-e053-2a95a90ad6a4abad9d47-78cc-0fcf-e053-2a95a90ad6a42020-07-30WarningsExact identifier
spl id: abad9d47-78cd-0fcf-e053-2a95a90ad6a4
spl set id: abad9d47-78cc-0fcf-e053-2a95a90ad6a4

Reported adverse events (FAERS/openFDA)#

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