FDA.reportPublic FDA data

palmpalm Hand Sanitizer Gel

Manufacturer
PALMPALM, LLC | RealChem Manufacturing Inc
Effective date
2020-08-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:25:17

Label at a glance#

Productpalmpalm 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

Purified Water, PEG-6 (and) AMP-Acrylates/Vinyl Isodecanoate Crosspolymer, Glycerin, Fragrance (Parfum).

Questions?

OTC - QUESTIONS SECTION

+1-888-659-0892
You may also report serious side effects to this phone number.
Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

Non-sterile Solution

Cucumber Melon Scent

Made in U.S.A.

KILLS GERMS IN SECONDS

WARRANTY DISCLAIMER
Because of conditions of use which may be beyond our control, palmpalm, LLC, shall not be held responsible in any manner for any personal injury or property loss resulting to the buyer or any other person from handling, storage, or use of this material not in line with directions. The buyer and/or user assumes all risk and liability resulting from improper handling or usage. There is no warranty expressed or implied of any kind, except as supplied in writing.

www.palmtopalm.com

info@palmtopalm.com

Manufactured by: palmpalm, LLC 220 Laurel Rd, Ste 204, Voorhees, NJ 08043

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
79719-100-012022-01-28C16284748780-1d6a99b39-cf97-a426-e053-dadaa90af4c2palmpalm Hand Sanitizer Gel
79719-100-022022-01-28C16284748780-1d6a99b39-cf97-a426-e053-dadaa90af4c2palmpalm Hand Sanitizer Gel
79719-100-032022-01-28C16284748780-1d6a99b39-cf97-a426-e053-dadaa90af4c2palmpalm Hand Sanitizer Gel
79719-100-042022-01-28C16284748780-1d6a99b39-cf97-a426-e053-dadaa90af4c2palmpalm Hand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79719-100-01palmpalm Hand Sanitizer60 mL in 1 BOTTLEGEL601
79719-100-02palmpalm Hand Sanitizer237 mL in 1 BOTTLEGEL2371
79719-100-03palmpalm Hand Sanitizer500 mL in 1 BOTTLEGEL5001
79719-100-04palmpalm Hand Sanitizer3785 mL in 1 BOTTLEGEL37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79719-100PALMPALM HAND SANITIZER (ETHYL ALCOHOL) GEL [PALMPALM, LLC]1Legacy NDC, 4 package rows20200821_40ffb4d5-f982-407a-852b-a34ceffc52a7.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79719-10079719-100-01, 79719-100-02, 79719-100-03, 79719-100-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%)2N8MDB79NAIACT
GLYCERINPDC6A3C0OXIACT

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
4f80f32b-a164-461f-8762-042b2eb972a840ffb4d5-f982-407a-852b-a34ceffc52a72020-08-17WarningsExact identifier
spl id: 4f80f32b-a164-461f-8762-042b2eb972a8
spl set id: 40ffb4d5-f982-407a-852b-a34ceffc52a7

Reported adverse events (FAERS/openFDA)#

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