Ovation
FDA Label NDC 67858-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Questspecialty Corporation for the product Ovation (NDC 67858-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Benzenethonium chloride USP 0.2%

Purpose

Sanitizer

Uses

Handwash to help decrease bacteria on the skin.

Recommended for repeated use.

Warnings

For external use only

Do Not Use

In the eyes.

When Using This Product

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

Skin irritation develops.

Keep Out Of Reach Of Children.

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

Inactive Ingredients

Water, glycerin, dimethicone, DMDM Hydantoin, isdopropynyl butylcarbamate, fragrance, hydroxyethyl cellulose

Directions

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.

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