Label: PREOP- hydrogen peroxide rinse
PREOP- pre-treatment antiseptic rinse rinse
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Contains inactivated NDC Code(s)
NDC Code(s): 72655-200-01, 72655-201-01 - Packager: Everbrands, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated March 8, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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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
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PREOP
hydrogen peroxide rinseProduct 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 rinseProduct 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)