FDA.reportPublic FDA data

OPLUS Antiseptic Instant Hand Sanitizer

Manufacturer
TDC USA Inc | Opal Cosmetics (Huizhou) Limited
Effective date
2020-07-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:19:48

Label at a glance#

ProductOPLUS Antiseptic Instant Hand Sanitizer
Active ingredientALCOHOL
Label structure7 sections

Dosage and administration

wet hands thoroughly with product and allow to dry without wiping

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 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 - 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 and allow to dry without wiping

Other information

SPL UNCLASSIFIED SECTION

  • do not store above 105°F (41°C)
  • 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79204-000-002022-01-28C16284748780-1d6a99b39-dda2-a426-e053-dadaa90af4c2OPLUS Antiseptic Instant Hand Sanitizer

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79204-000OPLUS ANTISEPTIC INSTANT HAND SANITIZER (ALCOHOL) GEL [TDC USA INC]3Legacy NDC20200731_df15a4ae-c420-4cae-940a-7a75b884afa2.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79204-00079204-000-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
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
a9da7642-4b00-1fb4-e053-2a95a90af0a3df15a4ae-c420-4cae-940a-7a75b884afa22020-07-07WarningsExact identifier
spl id: a9da7642-4b00-1fb4-e053-2a95a90af0a3
spl set id: df15a4ae-c420-4cae-940a-7a75b884afa2

Reported adverse events (FAERS/openFDA)#

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