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  5. Label Information: Preop

FDA Label for Preop

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - ACTIVE INGREDIENT
    3. OTC - PURPOSE
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DOSAGE & ADMINISTRATION
    10. OTHER SAFETY INFORMATION
    11. INACTIVE INGREDIENT
    12. OTC - QUESTIONS
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Preop Product Label

The following document was submitted to the FDA by the labeler of this product Everbrands, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

Bubble Gum

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