PREOP- hydrogen peroxide rinse PREOP- pre-treatment antiseptic rinse rinse

PREOP by

Drug Labeling and Warnings

PREOP by is a Otc medication manufactured, distributed, or labeled by Everbrands, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT

​Active ingredient

Hydrogen Peroxide 2.65%​​

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.

WHEN USING

When using this product, do not swallow

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

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

QUESTIONS

Questions?  +1 (855) 595-2999

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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INGREDIENTS AND APPEARANCE

PREOP 
hydrogen peroxide rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72655-200
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	26.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ETIDRONIC ACID (UNII: M2F465ROXU)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHA ARVENSIS FLOWER OIL (UNII: Q129Z1W6Y2)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72655-200-01	475 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/01/2021

PREOP 
pre-treatment antiseptic rinse rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72655-201
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	26.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ETIDRONIC ACID (UNII: M2F465ROXU)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72655-201-01	475 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/01/2021

Labeler - Everbrands, Inc. (080314845)

Registrant - Everbrands, Inc. (080314845)

Establishment
Name	Address	ID/FEI	Business Operations
Everbrands, Inc.		080314845	manufacture(72655-200, 72655-201)