Antimicrobial Hand Gel

Manufacturer
Calego International Inc.
Effective date
2020-05-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:13:13

Label at a glance#

ProductAntimicrobial Hand
Active ingredientALCOHOL
Label structure7 sections

Dosage and administration

put enough gel in your palm to cover hands and rub hands together rapidly until dry children under 6 years of age should be supervised when using this product

Storage and handling

store below 110 o F (43 o C) may discolor certain fabrics or surfaces

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% w/w

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

hand sanitizer to help reduce microbes on the skin

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame

For external use only.

When using this product,

OTC - WHEN USING SECTION

do not use in or near the eyes. If contact occurs, rinse thoroughly with water

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation and redness develops and persists for more than 72 hours and continues

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • put enough gel in your palm to cover hands and rub hands together rapidly until dry
  • children under 6 years of age should be supervised when using this product

Other information

STORAGE AND HANDLING SECTION

  • store below 110 oF (43 oC)
  • may discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer, fragrance, glycerin, propylene glycol, silicone, triethanolamine, water (aqua)

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle60mlBottle60ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72487-008-022021-07-23C16284748780-1c7ccaba7-22e0-fd44-e053-dadaa90aa01bAntimicrobial Hand Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72487-008-02Antimicrobial Hand60 mL in 1 BOTTLEGEL601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72487-008ANTIMICROBIAL HAND (ALCOHOL) GEL [CALEGO INTERNATIONAL INC.]1Legacy NDC, 1 package rows20200515_f52f07f7-0ed5-493a-b5e0-d5d45027f94a.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
72487-00872487-008-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML · Source PDF

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
a59994c8-6884-378e-e053-2a95a90af92bf52f07f7-0ed5-493a-b5e0-d5d45027f94a2020-05-14WarningsExact identifier
spl id: a59994c8-6884-378e-e053-2a95a90af92b
spl set id: f52f07f7-0ed5-493a-b5e0-d5d45027f94a

Reported adverse events (FAERS/openFDA)#

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