FDA.reportPublic FDA data

R and Co PALM READER ANTISEPTIC HAND SANITIZER

Manufacturer
220 Laboratories Inc.
Effective date
2022-02-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:48:30

Label at a glance#

ProductR and Co PALM READER ANTISEPTIC HAND SANITIZER
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

• hand sanitizer to decrease bacteria on the skin • recommended for repeated use • for use when soap and water are not available

Dosage and administration

• wet hands thoroughly with product and allow to dry without wiping • supervise children under 6 years of age when using this product to avoid swallowing

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

Uses

INDICATIONS & USAGE SECTION

• hand sanitizer to decrease bacteria on the skin
• recommended for repeated use
• for use when soap and water are not available

Warnings

WARNINGS SECTION

Flammable, keep away from fire/flame
For external use only

Do not use

• in children less than 2 months of age
• on open skin wounds

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if
• irritation and redness develop
• condition persists 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 with product and allow to dry without wiping
• supervise children under 6 years of age when using this product to avoid swallowing

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

aloe vera (Aloe barbadensis) leaf juice, aminomethyl propanol, bladderwrack (Fucus vesiculosus) extract, brown algae (Laminaria hyperborea) extract, carbomer, dead sea salt (Maris sal), fragrance, glycerin, kelp (Laminaria digitata) extract, potassium sorbate, propanediol, propylene glycol, sodium benzoate, sodium hyaluronate, tocopheryl acetate, water (aqua)

Questions? 1-855-726-3265

OTC - QUESTIONS SECTION

You may also report serious side effects to this phone number.

Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

PALM READER

Distributed by: Rogue & Co. LLC., Miami, FL 33137

Bottle comprised of 55% PCR

Lot No:
Expiry:

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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
57367-202-302024-01-30C16284748780-1d6a99b39-ce6c-a426-e053-dadaa90af4c2R and Co ANTISEPTIC HAND SANITIZER
57367-202-302022-02-25C16284748780-1d6a99b39-ce6c-a426-e053-dadaa90af4c2R and Co ANTISEPTIC HAND SANITIZER
57367-202-302022-01-28C16284748780-1d6a99b39-ce6c-a426-e053-dadaa90af4c2R and Co ANTISEPTIC HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57367-202-30R and Co PALM READER ANTISEPTIC HAND SANITIZER177 mL in 1 BOTTLEGEL1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57367-202R AND CO PALM READER ANTISEPTIC HAND SANITIZER (ETHYL ALCOHOL) GEL [220 LABORATORIES INC.]2Legacy NDC, 1 package rows20220226_73d37992-10d7-4bbb-a1da-e7b46cd03646.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57367-20257367-202-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
ALOE VERA LEAFZY81Z83H0XIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
FUCUS VESICULOSUS535G2ABX9MIACT
LAMINARIA HYPERBOREANXA595GQ1KIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
SEA SALT87GE52P74GIACT
GLYCERINPDC6A3C0OXIACT
LAMINARIA DIGITATA15E7C67EE8IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPANEDIOL5965N8W85TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM BENZOATEOJ245FE5EUIACT
HYALURONATE SODIUMYSE9PPT4THIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT

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
961cd1e7-b1c9-46e0-b316-af3cff4cef0e73d37992-10d7-4bbb-a1da-e7b46cd036462022-02-25WarningsExact identifier
spl id: 961cd1e7-b1c9-46e0-b316-af3cff4cef0e
spl set id: 73d37992-10d7-4bbb-a1da-e7b46cd03646

Reported adverse events (FAERS/openFDA)#

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