FDA.reportPublic FDA data

PlaneAire Hands gel Lemon Carrotseed hand sanitizer

Manufacturer
EverywhereAire LLC
Effective date
2021-10-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:42:40

Label at a glance#

ProductPlaneAire Hands hand sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Wet hands thoroughly with product, rub hands, and allow to dry without wiping For children under 6 years of age, use only under adult supervision to avoid swallowing not recommended for infants Wet hands thoroughly with product, rub hands, and allow to dry without wiping For children under 6 years of age, use only under adult supervision to avoid swallowing not recommended for infants

Storage and handling

store between 15-30C (59-86F) do not store above 105F avoid freezing may discolor some fabrics may be harmful to some wood finishes and plastics

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol
  3. Sterile distilled water or boiled cold water
  4. Other inactive ingredients.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v.

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

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- on hands. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • on open wounds or near eyes.

OTC - WHEN USING SECTION

In case of contact with eyes, rinse eyes thoroughly with water.

Stop use if irritation or rash occurs. If conditon persists for more than 72 hours, consult a doctor

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 if irritation or rash occurs. If conditon persists for more than 72 hours, consult a doctor

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 with product, rub hands, and allow to dry without wiping
  • For children under 6 years of age, use only under adult supervision to avoid swallowing
  • not recommended for infants

Dosage and Administration 12/20

RECENT MAJOR CHANGES SECTION

Wet hands thoroughly with product, rub hands, and allow to dry without wiping
For children under 6 years of age, use only under adult supervision to avoid swallowing
not recommended for infants

Other information

STORAGE AND HANDLING SECTION

  • store between 15-30C (59-86F)
  • do not store above 105F
  • avoid freezing
  • may discolor some fabrics
  • may be harmful to some wood finishes and plastics

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera inner leaf, green tea extract, carbomer, glycerin, lemon oil, carrot seed oil, sodium hydroxide, water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PAH Label 80335-106-02PAH Label 80335-106-0260 mL NDC: 80335-106-02

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
80335-106-022024-01-30C16284748780-11030e365-3f68-111a-e063-dadaa90a10e2PlaneAire Hands gel Lemon Carrotseed hand sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80335-106-02PlaneAire Hands hand sanitizer60 mL in 1 BOTTLE, PUMPGEL602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80335-106PLANEAIRE HANDS HAND SANITIZER (ETHYL ALCOHOL) GEL [EVERYWHEREAIRE LLC]2Legacy NDC, 1 package rows20211009_b68a5d56-1a0d-755c-e053-2995a90a3954.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80335-10680335-106-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
GREEN TEA LEAFW2ZU1RY8B0IACT
LEMON OILI9GRO824LLIACT
CARROT SEED OIL595AO13F11IACT
CARBOMER 9804Q93RCW27EIACT
SODIUM HYDROXIDE55X04QC32IIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAF POLYSACCHARIDESW21O437517IACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
cdccc6db-e004-840f-e053-2a95a90a3bcfb68a5d56-1a0d-755c-e053-2995a90a39542021-10-07WarningsExact identifier
spl id: cdccc6db-e004-840f-e053-2a95a90a3bcf
spl set id: b68a5d56-1a0d-755c-e053-2995a90a3954

Reported adverse events (FAERS/openFDA)#

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