FDA.reportPublic FDA data

O Plus Instant Hand Sanitizer

Manufacturer
Opal Cosmetics (Huizhou) Limited
Effective date
2022-05-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:01:29

Label at a glance#

ProductO Plus Instant Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Dosage and administration

wet hands thoroughly with product allow to dry without wiping

Storage and handling

do not store above 105°F.  may discolor certain fabrics harmful to wood finishes and plastics

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

For hand washing to decrease bacetria on the skin

Warnings

WARNINGS SECTION

For external use only

Flammable, keep away from fire or flame.

Do not use

OTC - DO NOT USE SECTION

in the eyes

Stop use and ask a doctor if

OTC - STOP USE 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

DOSAGE & ADMINISTRATION SECTION

wet hands thoroughly with product allow to dry without wiping

Other information

STORAGE AND HANDLING SECTION

  • do not store above 105°F. 
  • may discolor certain fabrics
  • harmful to wood finishes and plastics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, glycerin, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, aminomethyl propanol, aloe vera leaf extract, denatonium benzoate, t-butyl alcohol, maltodextrin.

​Package Labeling: 42477-4408-3

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

95mL95mL

Package Labeling: 42477-4408-2

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500mL500mL

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
42477-440842477-4408-3, 42477-4408-2

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
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
ALOE VERA LEAFZY81Z83H0XIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
TERT-BUTYL ALCOHOLMD83SFE959IACT
MALTODEXTRIN7CVR7L4A2DIACT
ALCOHOL3K9958V90MACTIB

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
debddb7b-8016-64b5-e053-2995a90a6085a3312379-eb68-210f-e053-2a95a90ae1962022-05-11WarningsExact identifier
spl id: debddb7b-8016-64b5-e053-2995a90a6085
spl set id: a3312379-eb68-210f-e053-2a95a90ae196

Reported adverse events (FAERS/openFDA)#

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