FDA.reportPublic FDA data

Gel

Manufacturer
VS CHEM (1970) LIMITED | HARDAL GLOBAL CONSULTING LLC
Effective date
2020-07-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:20:47

Label at a glance#

ProductPlyfah Hand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75% v/v. Purpose: Antiseptic

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. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs.

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

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol Denat., Aqua, Propylene Glycol, Carbomer, Triethanolamine, Eucalyptus Globulus Leaf Oil, Menthol

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PLYFAH HAND SANITIZER

Refreshing Gel

Kills 99.99% of germ without water

For External Use Only

5050100100250250500500

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1305100ethanol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79230-001-002022-01-28C16284748780-1d6a99b39-767f-a426-e053-dadaa90af4c2Gel
79230-001-012022-01-28C16284748780-1d6a99b39-767f-a426-e053-dadaa90af4c2Gel
79230-001-022022-01-28C16284748780-1d6a99b39-767f-a426-e053-dadaa90af4c2Gel
79230-001-032022-01-28C16284748780-1d6a99b39-767f-a426-e053-dadaa90af4c2Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79230-001-00Plyfah Hand Sanitizer50 mL in 1 BOTTLE, PLASTICGEL501
79230-001-01Plyfah Hand Sanitizer100 mL in 1 BOTTLE, PLASTICGEL1001
79230-001-02Plyfah Hand Sanitizer250 mL in 1 BOTTLE, PLASTICGEL2501
79230-001-03Plyfah Hand Sanitizer500 mL in 1 BOTTLE, PLASTICGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79230-001PLYFAH HAND SANITIZER (ALCOHOL) GEL [VS CHEM (1970) LIMITED]1Legacy NDC, 4 package rows20200710_a9dca448-5512-413e-e053-2a95a90a8c66.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79230-00179230-001-00, 79230-001-01, 79230-001-02, 79230-001-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
TROLAMINE9O3K93S3TKIACT
EUCALYPTUS OIL2R04ONI662IACT

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
a9dc9af5-b3d2-4118-e053-2a95a90a4d70a9dca448-5512-413e-e053-2a95a90a8c662020-07-07WarningsExact identifier
spl id: a9dc9af5-b3d2-4118-e053-2a95a90a4d70
spl set id: a9dca448-5512-413e-e053-2a95a90a8c66

Reported adverse events (FAERS/openFDA)#

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