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Pre Treatment Foaming Rinse Prescribing Information

Package insert / product label
Generic name: hydrogen peroxide
Dosage form: oral liquid

PREOP™ RINSE
PRE TREATMENT
FOAMING RINSE

Instructions For Use
Prior to commencing dental procedures, dispense 2 pumps (4-5 ml)
of PreOp™ Rinse into a disposable paper cup and have patient rinse
and swish for 15 seconds. Optional: Seat patient in chair, have
patient rinse, and then instead of expectorating, use saliva ejector
to prevent sink contamination. After use, rinsing with water is
optional. For extended procedures, have patient rinse again.

Ingredients
Water, hydrogen peroxide, glycerine, PVP PEG, sodium lauryl
sulfate, sucralose, sodium citrate, sodium benzoate, etidronic acid,
organic mint oil or bubble gum flavor (based on front label).

Warnings/Precautions
If irritation (such as redness, swelling, soreness) of the gums or
mouth occurs, discontinue use & consult your dentist. Adult
supervision is required for use by children under 12. Avoid contact
with eyes, skin, or hair; flush with water if contact is made. Avoid
swallowing; do not induce vomiting. Do not apply directly to gums
or under tongue. Do not use if nursing or pregnant. Keep away
from sunlight & heat as contents may pressurize. Use of this
product is not intended to cure any disease. Not for systemic use.

Product Label

PREOP™ RINSE
PRE TREATMENT
FOAMING RINSE

SURFACTANT ENHANCED™

HYDROGEN PEROXIDE

Rx Only

475ml 16fl oz

Manufactured by EverBrands, Inc.
401 N. Oak St., Inglewood, CA 90302
eversmilewhite.com/preop
(855) 595-2999

72655-100

res

PREOP RINSE
hydrogen peroxide liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72655-100
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE3.8 mL in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POVIDONE K30 (UNII: U725QWY32X)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ETIDRONIC ACID (UNII: M2F465ROXU)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
Product Characteristics
Color Score
ShapeSize
FlavorBUBBLE GUM (May Contain) Imprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72655-100-01475 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product12/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/30/2020
Labeler - Everbrands, Inc. dba EverPure, Inc. (080314845)
Registrant - Everbrands, Inc. dba EverPure, Inc. (080314845)
Establishment
NameAddressID/FEIBusiness Operations
Everbrands, Inc. dba EverPure, Inc.080314845manufacture(72655-100)