FDA.reportPublic FDA data

Ovation

Manufacturer
QuestSpecialty Corporation
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 20:46:29

Label at a glance#

ProductOvation Instant Hand Sanitizer
Active ingredientBENZETHONIUM CHLORIDE
Label structure12 sections

Indications and uses

Handwash to help decrease bacteria on the skin. Recommended for repeated use.

Dosage and administration

Press dispenser twice to deliver two squirts (about a quarter size) of foaming product onto the palm of your hand. Rub hands together until hands are dry. Wash with soap and water at earliest opportunity.

Storage and handling

Store at room temperature

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzenethonium chloride USP 0.2%

Purpose

OTC - PURPOSE SECTION

Sanitizer

Uses

INDICATIONS & USAGE SECTION

Handwash to help decrease bacteria on the skin.

Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only

Do Not Use

OTC - DO NOT USE SECTION

In the eyes.

When using this product

OTC - WHEN USING SECTION

Do not get in eyes. If contact occurs, flush eyes with water and contact a doctor immediately. If swallowed, seek medical attention.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Skin irritation develops.

Directions

DOSAGE & ADMINISTRATION SECTION

Press dispenser twice to deliver two squirts (about a quarter size) of foaming product onto the palm of your hand. Rub hands together until hands are dry. Wash with soap and water at earliest opportunity.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Children under 6 years old should be supervised  by an adult when using this product   

Other Information

STORAGE AND HANDLING SECTION

Store at room temperature

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, glycerin, dimethicone, DMDM Hydantoin, Iodopropynyl butylcarbamate, fragrance, hydroxythyl cellulose.

Label Image

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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
67858-00167858-001-50, 67858-001-01

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
WATER059QF0KO0RIACT
HYDROXYPROPYL CELLULOSERFW2ET671PIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OIACT
DMDM HYDANTOINBYR0546TOWIACT
SODIUM HYDROXIDE55X04QC32IIACT
BENZETHONIUM CHLORIDEPH41D05744ACTIB

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
291994ad-065a-f62d-e063-6394a90af28390fffac7-71fe-44bb-a39b-10a4c235f3d22024-12-12WarningsExact identifier
spl id: 291994ad-065a-f62d-e063-6394a90af283
spl set id: 90fffac7-71fe-44bb-a39b-10a4c235f3d2

Reported adverse events (FAERS/openFDA)#

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