FDA.reportPublic FDA data

PK 99 Hand Sanitizer

Manufacturer
PHYLUS CO.,LTD
Effective date
2020-05-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:13:21

Label at a glance#

ProductPK 99 Hand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

■ Hand sanitizer to help reduce bacteria that potentially can cause disease.

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Water, Pine oil, Polyoxyethylene (40) Hydrogenated Castor Oil

PURPOSE

OTC - PURPOSE SECTION

Antiseptic

WARNINGS

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame
--------------------------------------------------------------------------------------------------------
When using this product ■ do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water ■ avoid contact with broken skin ■ do not inhale or ingest
--------------------------------------------------------------------------------------------------------
Stop use and ask a doctor if irritation or rash appears and lasts

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

INDICATIONS & USAGE SECTION

■ Hand sanitizer to help reduce bacteria that potentially can cause disease.

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

OTHER SAFETY INFORMATION

■ Store below 86℉(Between 1~30℃)
■ May discolor certain fabrics or surfaces

Package Label: PK-99 Hand Sanitizer 100mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottleImage of bottle

Package Label: PK-99 Hand Sanitizer 350mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottleImage of bottle

Package Label: PK-99 Hand Sanitizer 500mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottleImage of bottle

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77448-020-012024-01-30C16284748780-11030e365-1f48-111a-e063-dadaa90a10e266b38802-777b-4e0e-bed3-8c9580cd70e1
77448-020-022024-01-30C16284748780-11030e365-1f48-111a-e063-dadaa90a10e266b38802-777b-4e0e-bed3-8c9580cd70e1
77448-020-032024-01-30C16284748780-11030e365-1f48-111a-e063-dadaa90a10e266b38802-777b-4e0e-bed3-8c9580cd70e1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77448-020-01PK 99 Hand Sanitizer100 mL in 1 BOTTLE, SPRAYSPRAY1002
77448-020-02PK 99 Hand Sanitizer350 mL in 1 BOTTLE, SPRAYSPRAY3502
77448-020-03PK 99 Hand Sanitizer500 mL in 1 BOTTLE, SPRAYSPRAY5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77448-020PK 99 HAND SANITIZER (ALCOHOL) SPRAY [PHYLUS CO.,LTD]2Legacy NDC, 3 package rows20200518_66b38802-777b-4e0e-bed3-8c9580cd70e1.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77448-02077448-020-01, 77448-020-02, 77448-020-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
WHITE PINE OILHA5CX6676UIACT

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
30906904-031a-4a3f-8b9b-a8c6ac61c16766b38802-777b-4e0e-bed3-8c9580cd70e12020-05-18WarningsExact identifier
spl id: 30906904-031a-4a3f-8b9b-a8c6ac61c167
spl set id: 66b38802-777b-4e0e-bed3-8c9580cd70e1

Reported adverse events (FAERS/openFDA)#

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