Hand Sanitizer

Manufacturer
LABORATORIOS FARMACEUTICO Y DE COSMETICA PINEDA DE COLOMBIA SAS
Effective date
2020-06-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:17:47

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
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#

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Warnings

WARNINGS SECTION

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

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.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

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,hydrogen peroxide, purified water USP

active ingredient

OTC - ACTIVE INGREDIENT SECTION

ethyl alcohol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABELSLABELS250m l NDC: 78428-250-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN4
582753ethanol 0.7 ML/ML Topical SolutionSCD4
582753ethanol 70 % Topical SolutionSY4
582753ethyl alcohol 70 % Topical SolutionSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78428-350-012022-01-28C16284748780-1d6a99b39-8e8a-a426-e053-dadaa90af4c2HANDSANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78428-350-01Hand Sanitizer250 mL in 1 BOTTLELIQUID2504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78428-350HAND SANITIZER (ETHYL ALCOHOL) LIQUID [LABORATORIOS FARMACEUTICO Y DE COSMETICA PINEDA DE COLOMBIA SAS]4Legacy NDC, 1 package rows20200616_a79a4a74-38db-1b03-e053-2a95a90a8717.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
78428-35078428-350-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
a82707d1-5e34-5cbd-e053-2995a90a3070a79a4a74-38db-1b03-e053-2a95a90a87172020-06-15WarningsExact identifier
spl id: a82707d1-5e34-5cbd-e053-2995a90a3070
spl set id: a79a4a74-38db-1b03-e053-2a95a90a8717

Reported adverse events (FAERS/openFDA)#

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