FDA.reportPublic FDA data

STAYKLEAR

Manufacturer
eHealth Nexus LLC | Nutrix
Effective date
2024-06-24
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 00:14:08

Label at a glance#

ProductSTAYKLEAR
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Antiseptic rub and hand sanitizer to help reduce bacteria and viruses on skin that could cause disease. For use when soap and water are not available.

Dosage and administration

Wet hands thoroughly with product and rub hands together, palms, backs and nails and wrists, until dry, without wiping. Children under 6 years of age should be supervised when using this product. Wet hands thoroughly with product and rub hands together, palms, backs and nails, until dry, without wiping. Children under 6 years of age should be supervised when using this product.

Storage and handling

Store below 110° F (43 C). •Dried product may turn brown from copper oxide. •May discolor certain fabrics or surfaces.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 63% by volume

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Antiseptic rub and hand sanitizer to help reduce bacteria and viruses on skin that could cause disease. For use when soap and water are not available.

Warnings:

WARNINGS SECTION

Flammable. Keep away from fire and flame.

For external use only. Do not ingest.

When using this product, do not use in or near eyes.

In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor, if irritation or rash appears and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the 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 and rub hands together, palms, backs and nails and wrists, until dry, without wiping. Children under 6 years of age should be supervised when using this product.

Directions

RECENT MAJOR CHANGES SECTION

Wet hands thoroughly with product and rub hands together, palms, backs and nails, until dry, without wiping. Children under 6 years of age should be supervised when using this product.

Other Information:

STORAGE AND HANDLING SECTION

Store below 110° F (43 C).

•Dried product may turn brown from copper oxide.
•May discolor certain fabrics or surfaces.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water, glycerin, propylene glycol, sodium salicylate, panthenol,‡ sodium lauryl sulfate, salicylic acid, hydroxypropyl cellulose, lactic acid, niacinamide,** isopropyl myristate, fragrance, copper gluconate, benzoic acid, orange oil, adipic acid, acetic acid, glycine, sodium chloride. **Vitamin B3, ‡Pro-vitamin B5

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

StayKlear Label 01StayKlear Label 013.4 oz StayKlear 2023-04-05 23.4 oz StayKlear 2023-04-05 2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82140-432-01STAYKLEAR0.213 kg in 1 BOTTLE, PUMPLIQUID0.21311
82140-432-02STAYKLEAR0.053 kg in 1 BOTTLE, PUMPLIQUID0.05311
82140-432-03STAYKLEAR0.09 kg in 1 BOTTLE, PLASTICLIQUID0.0911

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82140-432STAYKLEAR (ALCOHOL) LIQUID [EHEALTH NEXUS LLC]11Current NDC, Legacy NDC, 3 package rows20240626_c8b31580-5672-61de-e053-2995a90a3e78.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82140-43282140-432-01, 82140-432-02, 82140-432-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
VANILLINCHI530446XIACT
BENZYL BENZOATEN863NB338GIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
LACTIC ACID33X04XA5ATIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
PANTHENOLWV9CM0O67ZIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM SALICYLATEWIQ1H85SYPIACT
GLYCERINPDC6A3C0OXIACT
SODIUM LAURYL SULFATE368GB5141JIACT
NIACINAMIDE25X51I8RD4IACT
ADIPIC ACID76A0JE0FKJIACT
BENZOIC ACID8SKN0B0MIMIACT
SALICYLIC ACIDO414PZ4LPZIACT
GLYCINETE7660XO1CIACT
COPPER GLUCONATERV823G6G67IACT
ACETIC ACIDQ40Q9N063PIACT
SODIUM CHLORIDE451W47IQ8XIACT
ORANGE OILAKN3KSD11BIACT

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
STAYKLEARALCOHOLeHealth Nexus LLCc8b31580-5672-61de-e053-2995a90a3e782024-06-24WarningsExact identifier
ndc (package): 82140-432-03
ndc (package): 82140-432-02
ndc (package): 82140-432-01
ndc (product): 82140-432
ndc11 (package): 82140043201
ndc11 (package): 82140043202
ndc11 (package): 82140043203
spl id: 1ba89f66-37a9-b647-e063-6394a90aac2a
spl set id: c8b31580-5672-61de-e053-2995a90a3e78

Reported adverse events (FAERS/openFDA)#

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