Hand Sanitizer

Manufacturer
Broncolin, S.A. de C.V
Effective date
2020-04-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:07:04

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

■ Wet hands throughhly with product,and allow to dry without wiping ■ For children under 6, use only with adult supervision ■ Not recommended for infants

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

■ To decrease bacteria on the skin that could cause disease. Recommended for repeated use.

Warnings

WARNINGS SECTION

Flammable. Keep away from fire & flame. For external use hands only

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ irritation or redness develops ■ conditions persist for more than 72 hours ■ redness is present

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, contact a doctor or Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

■ Wet hands throughhly with product,and allow to dry without wiping ■ For children under 6, use only with adult supervision ■ Not recommended for infants

Other information

SPL UNCLASSIFIED SECTION

■ Do not store above105ºF ■ May discolor some fabrics ■ Harmful to wood finishes and plastics

Inactive Ingredients

INACTIVE INGREDIENT SECTION

carbomer, glycerin, triethanolamine, water

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62583-020-08Hand Sanitizer250 mL in 1 BOTTLE, PLASTICGEL2502
62583-020-16Hand Sanitizer500 mL in 1 BOTTLE, PLASTICGEL5002
62583-020-33Hand Sanitizer1000 mL in 1 BOTTLE, PLASTICGEL10002
62583-020-42Hand Sanitizer125 mL in 1 BOTTLE, PLASTICGEL1252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62583-020HAND SANITIZER (ALCOHOL) GEL [BRONCOLIN, S.A. DE C.V]2Legacy NDC, 4 package rows20200421_a2ba4bff-d704-fe05-e053-2995a90a387c.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
62583-02062583-020-42, 62583-020-08, 62583-020-16, 62583-020-33

Ingredients#

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

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

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
a3be5bf7-3a65-2300-e053-2995a90a8a34a2ba4bff-d704-fe05-e053-2995a90a387c2020-04-20WarningsExact identifier
spl id: a3be5bf7-3a65-2300-e053-2995a90a8a34
spl set id: a2ba4bff-d704-fe05-e053-2995a90a387c

Reported adverse events (FAERS/openFDA)#

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