FDA.reportPublic FDA data

Protec Hand Sani Gel Antibacterial

Manufacturer
Degasa, S.A. de C.V.
Effective date
2023-11-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:00

Label at a glance#

ProductProtec Hand Sani Gel Antibacterial
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

To decrease bactreria on the skin that could disease.Recommended for repeated use.

Dosage and administration

- Wet hands thoroughly with product and allow to dry without wiping - For children under 6, use only under adults supervision - Not recommended for infants

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Deionized water, Carbopol, Glycerin, Triethanolamine, Aminomethylpropanol,Fragrance.

Uses

INDICATIONS & USAGE SECTION

To decrease bactreria on the skin that could disease.Recommended for repeated use.

When using this product :

OTC - WHEN USING SECTION

Keep out of eyes.In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest. 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

- For children under 6, use only under adults supervision

- Not recommended for infants

Other information

SPL UNCLASSIFIED SECTION

- Do not store above 105° F 

- Harmful to wood finishes and plastic

Warnings

WARNINGS SECTION

- For external use only: hands

- Flammable, keep away from fire or flame

- Keep out of reah of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67326-006-00Protec Hand Sani Gel Antibacterial118 mL in 1 BOTTLEGEL1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67326-006PROTEC HAND SANI GEL ANTIBACTERIAL (ALCOHOL) GEL [DEGASA, S.A. DE C.V.]2Current NDC, Legacy NDC, 1 package rows20231106_78f0fcd0-96eb-4432-8e2a-da4c6d70cf9a.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
67326-00667326-006-00

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
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
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
Protec Hand Sani Gel AntibacterialALCOHOLDegasa, S.A. de C.V.78f0fcd0-96eb-4432-8e2a-da4c6d70cf9a2023-11-05WarningsExact identifier
ndc (package): 67326-006-00
ndc (product): 67326-006
ndc11 (package): 67326000600
spl id: 09734dc8-5102-1bd0-e063-6394a90a90c0
spl set id: 78f0fcd0-96eb-4432-8e2a-da4c6d70cf9a

Reported adverse events (FAERS/openFDA)#

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