Hand Sanitizer Gel

Manufacturer
Califormulations LLC
Effective date
2020-08-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:24:27

Label at a glance#

ProductHand Sanitizer Gel
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

Wet hands thoroughly wit product to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product. Not recommended for infants.

Storage and handling

Avoid freezing and excessive heat above 40C (104F) May discolor certain fabrics or surfaces

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

Warnings

WARNINGS SECTION

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

OTC - WHEN USING SECTION

When using this product

  • Keep out of eyes. In case of contact with eyes, rinse eyes thoroughly with water
  • Avoid contact with broken skin
  • Do not inhale or ingest

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • irritation and redness develop
  • condition persist for more than 72 hours

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

  • Wet hands thoroughly wit product to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product.
  • Not recommended for infants.

Other information

STORAGE AND HANDLING SECTION

  • Avoid freezing and excessive heat above 40C (104F)
  • May discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Acrylates Copolymer, Aloe Barbadensis Leaf Juice, Triethanolamine, Frangrance (Parfum)

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

128oz Hand Sanitizer Gel128oz Hand Sanitizer Gel

3785 mL NDC: 74391-003-01 8oz Hand Sanitizer Gel8oz Hand Sanitizer Gel

237 mL NDC: 74391-003-08

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74391-003-012021-07-23C16284748780-1c7ccaba7-2697-fd44-e053-dadaa90aa01bHand Sanitizer Gel
74391-003-082021-07-23C16284748780-1c7ccaba7-2697-fd44-e053-dadaa90aa01bHand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74391-003-01Hand Sanitizer Gel3785 mL in 1 BOTTLEGEL37852
74391-003-08Hand Sanitizer Gel237 mL in 1 BOTTLEGEL2372

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74391-003HAND SANITIZER GEL (ALCOHOL) GEL [CALIFORMULATIONS LLC]2Legacy NDC, 2 package rows20200812_abf96af0-3fd1-5778-e053-2a95a90a9acd.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
74391-00374391-003-08, 74391-003-01

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
ac380c0d-dc7a-40d7-e053-2995a90a7d9fabf96af0-3fd1-5778-e053-2a95a90a9acd2020-08-06WarningsExact identifier
spl id: ac380c0d-dc7a-40d7-e053-2995a90a7d9f
spl set id: abf96af0-3fd1-5778-e053-2a95a90a9acd

Reported adverse events (FAERS/openFDA)#

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