FDA.reportPublic FDA data

Suave Hand Sanitizer Professional

Manufacturer
UNILEVER ASIA PRIVATE LIMITED
Effective date
2020-11-04
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:32:50

Label at a glance#

ProductSuave Hand Sanitizer Professional
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

Wet hands thoroughly with product and rub lightly until dry. Do not wipe off or rinse.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 75% v/v

PURPOSE

OTC - PURPOSE SECTION

ANTISEPTIC

USE

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

WARNINGS

WARNINGS SECTION

For External Use only. Highly flammable liquid and vapour. Keep away from/do not spray near heat, hot surfaces, sparks, electrical appliances, open flames and other ignition sources. Do not store in car. No smoking. Keep containers tightly closed.

Do Not Use

  • On children less than 2 months of age
  • On open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact, rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. Causes serious eye irritation. If swallowed, get medical help or contact Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Wet hands thoroughly with product and rub lightly until dry. Do not wipe off or rinse.

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • Store between 15-30ºC (59-86ºF)
  • Avoid freezing and excessive heat above 40ºC (104ºF)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Acrylates Copolymer, Aminomethyl Propanol, Denatonium Benzoate, Glycerin, Purified Water USP, Tert-butyl Alcohol, Triethanolamine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Suave_Hand Sani Gel_75pct_5000mL01b LBL_Suave_Hand Sani Gel_75pct_5000mL

01b LBL_Suave_Hand Sani Gel_75pct_50mL01b LBL_Suave_Hand Sani Gel_75pct_50mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN5
1305100ethanol 0.75 ML/ML Topical GelSCD5
1305100ethanol 75 % Topical GelSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50069-110-112022-01-28C16284748780-1d6a99b39-97d8-a426-e053-dadaa90af4c2Suave Hand Sanitizer Professional - 75% Ethyl Alcohol
50069-110-122022-01-28C16284748780-1d6a99b39-97d8-a426-e053-dadaa90af4c2Suave Hand Sanitizer Professional - 75% Ethyl Alcohol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50069-110-11Suave Hand Sanitizer Professional5000 mL in 1 BOTTLE, PUMPGEL50005
50069-110-12Suave Hand Sanitizer Professional50 mL in 1 BOTTLEGEL505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50069-110SUAVE HAND SANITIZER PROFESSIONAL (ALCOHOL) GEL [UNILEVER ASIA PRIVATE LIMITED]5Legacy NDC, 2 package rows20201105_2723679c-6505-4151-85a2-ab7b9882d866.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50069-11050069-110-11, 50069-110-12
73931-018

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)JZ1374NL9EIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
TERT-BUTYL ALCOHOLMD83SFE959IACT
TROLAMINE9O3K93S3TKIACT

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
085232be-fbba-4783-8111-df01f362b1b82723679c-6505-4151-85a2-ab7b9882d8662020-11-04WarningsExact identifier
spl id: 085232be-fbba-4783-8111-df01f362b1b8
spl set id: 2723679c-6505-4151-85a2-ab7b9882d866

Reported adverse events (FAERS/openFDA)#

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