FDA.reportPublic FDA data

Gel Sanitizer

Manufacturer
Mesa Lavender Farms
Effective date
2020-11-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:34:22

Label at a glance#

ProductHand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure12 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 below 110°F (43°C) May discolor certain fabrics or surfaces

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Isopropyl alcohol 70% v/v...................... Antiseptic

Active ingredient[s] Purpose

OTC - PURPOSE SECTION

Isopropyl alcohol 70% v/v...................... Antiseptic

Use[s]

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria that potentially can cause disease.

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

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

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 below 110°F (43°C)

May discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, carbomer, triethanolamine, fragrance, color additive

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

66 ml NDC: 80311-252-21

252 Front252 Front

252 Back252 Back

66 ml NDC: 80311-000-21

000 Front000 Front

000 Back000 Back

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80311-000-212022-01-28C16284748780-1d6a99b39-b436-a426-e053-dadaa90af4c2Gel Sanitizer
80311-252-212022-01-28C16284748780-1d6a99b39-b436-a426-e053-dadaa90af4c2Gel Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80311-000-21Hand Sanitizer66 mL in 1 BOTTLE, PLASTICGEL664
80311-252-21Hand Sanitizer66 mL in 1 BOTTLE, PLASTICGEL664

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80311-000HAND SANITIZER (ISOPROPYL ALCOHOL) GEL [MESA LAVENDER FARMS]4Legacy NDC, 1 package rows20201130_ad3045b9-9846-9149-e053-2995a90a66cb.zip
80311-252HAND SANITIZER (ISOPROPYL ALCOHOL) GEL [MESA LAVENDER FARMS]4Legacy NDC, 1 package rows20201130_ad3045b9-9846-9149-e053-2995a90a66cb.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80311-25280311-252-21
80311-00080311-000-21

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C RED NO. 40WZB9127XOAIACT
LINALOOL, (+/-)-D81QY6I88EIACT
ISOPROPYL ALCOHOLND2M416302ACTIB
CARBOMER 9404Q93RCW27EIACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GLYCERINPDC6A3C0OXIACT
NONOXYNOL-948Q180SH9TIACT
LIMONENE, (+)-GFD7C86Q1WIACT
METHYL IONONESEL78BGX1LOIACT
WATER059QF0KO0RIACT
LINALOOL, (+/-)-D81QY6I88EIACT
ISOPROPYL ALCOHOLND2M416302ACTIB
CARBOMER 9404Q93RCW27EIACT
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
NONOXYNOL-948Q180SH9TIACT

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
b543edbd-c9d1-76bd-e053-2a95a90a5987ad3045b9-9846-9149-e053-2995a90a66cb2020-11-29WarningsExact identifier
spl id: b543edbd-c9d1-76bd-e053-2a95a90a5987
spl set id: ad3045b9-9846-9149-e053-2995a90a66cb

Reported adverse events (FAERS/openFDA)#

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