PREOP- hydrogen peroxide rinse 
Everbrands, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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PREOP Pre-Treatment Antiseptic Rinse

DRUG FACTS

​Active ingredient

Hydrogen Peroxide 2.65%​​

Purpose

antiseptic oral rinse

Uses

Warnings

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

When using this product, do not swallow

Stop use and ask a doctor if

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.

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

Inactive Ingredients:

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

citrate, sodium lauryl sulfate, sucralose, water

Questions?  +1 (855) 595-2999

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

PreOp_Mint_16oz

Bubble Gum

PreOp-BGum 16oz

res

PREOP 
hydrogen peroxide rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72655-200
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE26.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72655-200-01475 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/01/2021
PREOP 
pre-treatment antiseptic rinse rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72655-201
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE26.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72655-201-01475 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/01/2021
Labeler - Everbrands, Inc. (080314845)
Registrant - Everbrands, Inc. (080314845)
Establishment
NameAddressID/FEIBusiness Operations
Everbrands, Inc.080314845manufacture(72655-200, 72655-201)

Revised: 3/2021
Document Id: f1a5754f-d292-44e8-9489-b91c8efc62c2
Set id: cc5cdd29-92c1-4ce0-997e-eb624b288b09
Version: 1
Effective Time: 20210308
 
Everbrands, Inc.