CALPAK

Manufacturer
CALIFORNIA PAK INTERNATIONAL, INC
Effective date
2020-09-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:32:39

Label at a glance#

ProductCALPAK
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. Do not use other than directed.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% 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

OTC - DO NOT USE SECTION

Do not use 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 occurs. 

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.
  • Do not use other than directed.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua/Water/Eau, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Fragrance/Parfum, Glycerin, Isopropyl Myristate, Triethanolamine.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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
80543-001-012022-01-28C16284748780-1d6a99b39-fc24-a426-e053-dadaa90af4c2681698e7-3ec7-4093-83e3-e30d8e6e1245
80543-001-022022-01-28C16284748780-1d6a99b39-fc24-a426-e053-dadaa90af4c2681698e7-3ec7-4093-83e3-e30d8e6e1245

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80543-001-01CALPAK53 mL in 1 BOTTLE, PLASTICGEL531
80543-001-02CALPAK236 mL in 1 BOTTLE, PLASTICGEL2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80543-001CALPAK (ALCOHOL) GEL [CALIFORNIA PAK INTERNATIONAL, INC]1Legacy NDC, 2 package rows20201031_681698e7-3ec7-4093-83e3-e30d8e6e1245.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
80543-00180543-001-01, 80543-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
14885d2c-d4c2-4e6e-a91a-6cb5901f906c681698e7-3ec7-4093-83e3-e30d8e6e12452020-09-30WarningsExact identifier
spl id: 14885d2c-d4c2-4e6e-a91a-6cb5901f906c
spl set id: 681698e7-3ec7-4093-83e3-e30d8e6e1245

Reported adverse events (FAERS/openFDA)#

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