Preop Rinse
FDA Label NDC 72655-200

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Everbrands, Inc. for the product Preop (NDC 72655-200). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - 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

Other

DRUG FACTS

Otc - Active Ingredient

​Active ingredient

Hydrogen Peroxide 2.65%​​

Otc - Purpose

Purpose

antiseptic oral rinse

Indications & Usage

Uses

  • for dental procedural rinsing
  • to help prevent infection in minor oral irritations

Warnings

Warnings

Do not use this product for more than 7 days unless directed by a dentist or physician.

Otc - When Using

When using this product, do not swallow

Otc - Stop Use

Stop use and ask a doctor if

  • sore mouth symptoms do not improve within 7 days
  • irritations, pain or redness persists or worsens
  • swelling, rash or fever develops

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If more than used for rinsing is accidentally

swallowed, get medical help or contact a poison Control Center right away.

Dosage & Administration

Directions:
• Adults and children 2 years of age and older: rinse two pumps (4-5 mL)
  around in the mouth over the affected area for at least 15 seconds, then spit out
• Children under 12 years of age should be supervised in the use of this product
• Children under 2 years of age: consult a dentist or physician

Other Safety Information

Other Informationstore at controlled room temperature 68-77°F (20 - 25°C)

Inactive Ingredient

Inactive Ingredients:

Etidronic acid, glycerine, menthe arvensis oil, PEG, PVP, sodium benzoate, sodium

citrate, sodium lauryl sulfate, sucralose, water

Otc - Questions

Questions?  +1 (855) 595-2999

Package Label.Principal Display Panel

EverSmile

PREOP​™

PRE-TREATMENT

ANTISEPTIC RINSE

HYDROGEN PEROXIDE

EXPANDING  FOAM

16 FL OZ (475 mL)

Manufactured by EverBrands, Inc

401 N. Oak St., Inglewood, CA 90302

eversmilewhite.com/preop

+1 (855) 595-2999

Mint

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