FDA.reportPublic FDA data

B-Protek

Manufacturer
Grupo Siller Ingeniería Construcción y Materiales, S.A. de C.V
Effective date
2020-09-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:30:14

Label at a glance#

ProductB-Protek
Active ingredientISOPROPYL ALCOHOL
Label structure11 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 80% 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. Flammable. Keep away from heat or flame.

Do not mix use with other household chemicals.

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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 hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, carbomer 940, aloe vera extract, vitamin E, purified water.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2397699isopropyl alcohol 80 % Topical GelPSN1
2397699isopropyl alcohol 0.8 ML/ML Topical GelSCD1
2397699isopropyl alcohol 80 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80308-002-012022-01-28C16284748780-1d6a99b39-626b-a426-e053-dadaa90af4c2684bbfc0-fc95-400e-a77d-3e827db3ce57
80308-002-022022-01-28C16284748780-1d6a99b39-626b-a426-e053-dadaa90af4c2684bbfc0-fc95-400e-a77d-3e827db3ce57
80308-002-032022-01-28C16284748780-1d6a99b39-626b-a426-e053-dadaa90af4c2684bbfc0-fc95-400e-a77d-3e827db3ce57
80308-002-042022-01-28C16284748780-1d6a99b39-626b-a426-e053-dadaa90af4c2684bbfc0-fc95-400e-a77d-3e827db3ce57
80308-002-052022-01-28C16284748780-1d6a99b39-626b-a426-e053-dadaa90af4c2684bbfc0-fc95-400e-a77d-3e827db3ce57
80308-002-062022-01-28C16284748780-1d6a99b39-626b-a426-e053-dadaa90af4c2684bbfc0-fc95-400e-a77d-3e827db3ce57
80308-002-072022-01-28C16284748780-1d6a99b39-626b-a426-e053-dadaa90af4c2684bbfc0-fc95-400e-a77d-3e827db3ce57

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80308-002-01B-Protek3 mL in 1 POUCHGEL31
80308-002-02B-Protek30 mL in 1 BOTTLE, PLASTICGEL301
80308-002-03B-Protek60 mL in 1 BOTTLE, PLASTICGEL601
80308-002-04B-Protek250 mL in 1 BOTTLE, PLASTICGEL2501
80308-002-05B-Protek500 mL in 1 BOTTLE, PLASTICGEL5001
80308-002-06B-Protek1000 mL in 1 BOTTLE, PLASTICGEL10001
80308-002-07B-Protek3785 mL in 1 BOTTLE, PLASTICGEL37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80308-002B-PROTEK (ISOPROPYL ALCOHOL) GEL [GRUPO SILLER INGENIERÍA CONSTRUCCIÓN Y MATERIALES, S.A. DE C.V]1Legacy NDC, 7 package rows20200926_684bbfc0-fc95-400e-a77d-3e827db3ce57.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80308-00280308-002-01, 80308-002-02, 80308-002-03, 80308-002-04, 80308-002-05, 80308-002-06, 80308-002-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302ACTIB
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
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
dfecdd36-2e4f-46b9-9e1c-fad36ffedd48684bbfc0-fc95-400e-a77d-3e827db3ce572020-09-24WarningsExact identifier
spl id: dfecdd36-2e4f-46b9-9e1c-fad36ffedd48
spl set id: 684bbfc0-fc95-400e-a77d-3e827db3ce57

Reported adverse events (FAERS/openFDA)#

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