FDA.reportPublic FDA data

HAND SANITIZER GEL

Manufacturer
REALITY PHARMA, S.A. DE C.V.
Effective date
2020-06-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:15:49

Label at a glance#

ProductHAND SANITIZER
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

Directions Place enough product on hands to cover all surfaces. Rub hands together until dry.

Label contents#

Full prescribing information#

DOSAGE

DOSAGE & ADMINISTRATION SECTION

Place enough product on hands to cover all surfaces. Rub hands together until dry.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Inactive ingredients Water (Aqua), Glycerin, Carbomer, Triethanolamine

DIRECTIONS

INDICATIONS & USAGE SECTION

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

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.

PURPOSE

OTC - PURPOSE SECTION

PURPOSE ANTIMICROBIAL

WARNINGS

WARNINGS SECTION

Warnings

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

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredient. Ethyl Alcohol 70% v/v

STOP USE ASK A DOCTOR

OTC - ASK DOCTOR SECTION

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

PRINCIPAL DISPLAY

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABEL 125 ml FINALLABEL 125 ml FINALLABEL 250 mlLABEL 250 mlLABLE 1000 mLLABLE 1000 mLLABEL 500 mLLABEL 500 mL

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
78525-2000-22022-01-28C16284748780-1d6a99b39-741e-a426-e053-dadaa90af4c2HAND SANITIZER GEL
78525-2000-32022-01-28C16284748780-1d6a99b39-741e-a426-e053-dadaa90af4c2HAND SANITIZER GEL
78525-2000-42022-01-28C16284748780-1d6a99b39-741e-a426-e053-dadaa90af4c2HAND SANITIZER GEL
78525-2000-52022-01-28C16284748780-1d6a99b39-741e-a426-e053-dadaa90af4c2HAND SANITIZER GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78525-2000-2HAND SANITIZER125 mL in 1 BOTTLEGEL1251
78525-2000-3HAND SANITIZER250 mL in 1 BOTTLEGEL2501
78525-2000-4HAND SANITIZER500 mL in 1 BOTTLEGEL5001
78525-2000-5HAND SANITIZER1000 mL in 1 BOTTLEGEL10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78525-2000HAND SANITIZER (ALCOHOL) GEL [REALITY PHARMA, S.A. DE C.V.]1Legacy NDC, 4 package rows20200603_a716238a-e60b-6614-e053-2a95a90a95a1.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
78525-200078525-2000-2, 78525-2000-3, 78525-2000-4, 78525-2000-5

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
TRIETHANOLAMINE CAPROYL GLUTAMATE0F2FO57253IACT
CARBOMER 9404Q93RCW27EIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT

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
a716238a-e60c-6614-e053-2a95a90a95a1a716238a-e60b-6614-e053-2a95a90a95a12020-06-02WarningsExact identifier
spl id: a716238a-e60c-6614-e053-2a95a90a95a1
spl set id: a716238a-e60b-6614-e053-2a95a90a95a1

Reported adverse events (FAERS/openFDA)#

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