FDA.reportPublic FDA data

PALMIST ANTISEPTIC HAND SANITIZER

Manufacturer
POCKET INC
Effective date
2020-10-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:32:39

Label at a glance#

ProductPALMIST 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

benzalkonium chloride, carbomer, holy basil (Ocimum tenuiflorum), lemon (Citrus medica limonum) oil, neem (Azadirachta indica) leaf extract, triethanolamine, water

Questions?

OTC - QUESTIONS SECTION

+1-412-999-4501

You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

Distributed by: LSM DISTRIBUTION LLC.
312 WEST 7th AVENUE, WEST HOMESTEAD, PA 15120

MADE IN INDIA

Ismdistributionllc@gmail.com

www.palmist.net

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

untitleduntitled

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80636-101-012022-01-28C16284748780-1d6a99b39-7e98-a426-e053-dadaa90af4c2PALMIST TM ANTISEPTIC HAND SANITIZER
80636-101-202022-01-28C16284748780-1d6a99b39-7e98-a426-e053-dadaa90af4c2PALMIST TM ANTISEPTIC HAND SANITIZER
80636-101-302022-01-28C16284748780-1d6a99b39-7e98-a426-e053-dadaa90af4c2PALMIST TM ANTISEPTIC HAND SANITIZER
80636-101-402022-01-28C16284748780-1d6a99b39-7e98-a426-e053-dadaa90af4c2PALMIST TM ANTISEPTIC HAND SANITIZER
80636-101-452022-01-28C16284748780-1d6a99b39-7e98-a426-e053-dadaa90af4c2PALMIST TM ANTISEPTIC HAND SANITIZER
80636-101-602022-01-28C16284748780-1d6a99b39-7e98-a426-e053-dadaa90af4c2PALMIST TM ANTISEPTIC HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80636-101-01PALMIST ANTISEPTIC HAND SANITIZER1 mL in 1 PACKETGEL11
80636-101-01PALMIST ANTISEPTIC HAND SANITIZER30 in 1 BOXGEL301
80636-101-20PALMIST ANTISEPTIC HAND SANITIZER200 in 1 BAGGEL2001
80636-101-20PALMIST ANTISEPTIC HAND SANITIZER1 mL in 1 PACKETGEL11
80636-101-30PALMIST ANTISEPTIC HAND SANITIZER200 in 1 BAGGEL2001
80636-101-30PALMIST ANTISEPTIC HAND SANITIZER1.5 mL in 1 PACKETGEL1.51
80636-101-40PALMIST ANTISEPTIC HAND SANITIZER200 in 1 BAGGEL2001
80636-101-40PALMIST ANTISEPTIC HAND SANITIZER2 mL in 1 PACKETGEL21
80636-101-45PALMIST ANTISEPTIC HAND SANITIZER1.5 mL in 1 PACKETGEL1.51
80636-101-45PALMIST ANTISEPTIC HAND SANITIZER30 in 1 BOXGEL301
80636-101-60PALMIST ANTISEPTIC HAND SANITIZER30 in 1 BOXGEL301
80636-101-60PALMIST ANTISEPTIC HAND SANITIZER2 mL in 1 PACKETGEL21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80636-101PALMIST ANTISEPTIC HAND SANITIZER (ETHYL ALCOHOL) GEL [POCKET INC]1Legacy NDC, 12 package rows20201031_9095e8da-6f3f-4f7a-8adf-46df15845987.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80636-10180636-101-01, 80636-101-20, 80636-101-45, 80636-101-30, 80636-101-60, 80636-101-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
HOLY BASIL LEAFSCJ765569PIACT
LEMON OILI9GRO824LLIACT
AZADIRACHTA INDICA LEAFHKY915780TIACT
TROLAMINE9O3K93S3TKIACT
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
f127f29e-be1f-4ca5-a408-40dbbe5fe0249095e8da-6f3f-4f7a-8adf-46df158459872020-10-27WarningsExact identifier
spl id: f127f29e-be1f-4ca5-a408-40dbbe5fe024
spl set id: 9095e8da-6f3f-4f7a-8adf-46df15845987

Reported adverse events (FAERS/openFDA)#

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