FDA.reportPublic FDA data

PUREASE STERILIZE ANTISEPTIC HAND SANITIZER Gel

Manufacturer
Beauty Plus Trading Co., Inc | Devolver Cosmetics Co., Ltd
Effective date
2020-05-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:29:10

Label at a glance#

ProductPUREASE STERILIZE ANTISEPTIC HAND SANITIZER Gel
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

wet hands thoroughly with product and allow to dry without wiping

Storage and handling

Store below 106F (41C) May discolor certain fabrics or surfaces

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

DOSAGE & ADMINISTRATION SECTION

For hand washing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

For external use only.

Flammable, keep away from fire or flame.

Do not use

OTC - WHEN USING SECTION

in the eyes

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

irritation and redness develop

condition persists for more than 72 hours

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.

Directions

INDICATIONS & USAGE SECTION

wet hands thoroughly with product and allow to dry without wiping

Other information

STORAGE AND HANDLING SECTION

Store below 106F (41C)

May discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Glycerin, Carbomers, Mentha Herb Oil, Trolamine, Aleo Extract(09), Parsley Extract

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3785ml NDC: 78399-201-013785ml NDC: 78399-201-01

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78399-20178399-201-01

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
ALOEV5VD430YW9IACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
MENTHA ARVENSIS TOP8J5Y2F7A5XIACT
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
PARSLEY58FMD0Q0EVIACT
TROLAMINE9O3K93S3TKIACT

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
b560beef-a3f5-df05-e053-2995a90a16eea67bfbf8-bb38-8fa8-e053-2995a90adfff2020-11-30WarningsExact identifier
spl set id: a67bfbf8-bb38-8fa8-e053-2995a90adfff