Label: PEROXYL MOUTH SORE MILD MINT- hydrogen peroxide rinse

  • NDC Code(s): 0126-0083-70
  • Packager: Colgate Oral Pharmaceuticals, 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 September 8, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 10 mL)

    Hydrogen peroxide 150 mg

  • Purpose

    oral debriding agent

  • Use

    oral debriding agent/oral wound cleanser for temporary use to cleanse canker sores and minor wounds or minor gum inf ammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums such as mouth burns, cheek bites and toothbrush abrasions.

  • 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
      • sore mouth symptoms do not improve within 7 days
      • irritation, pain or redness persists or worsens
      • swelling, rash or fever develops

    • 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 contents of this package (two teaspoons) around in the mouth over affected area for at least 1 minute, then spit out
    • use up to 4 times daily after meals and at bedtime or as directed by dentist or physician
    • children under 12 years of age should be supervised in the use of the product
    • children under 2 years of age: consult a dentist or physician
  • Other information

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

  • Inactive ingredients

    water, sorbitol, propylene glycol, poloxamer 338, polysorbate 20, methyl salicylate, menthol, sodium saccharin, FD&C blue no.1

  • Questions?

    1-800-962-2345

  • PRINCIPAL DISPLAY PANEL - 50 Packet Carton

    Colgate®

    Peroxyl®

    MOUTH SORE
    RINSE
    ALCOHOL-FREE
    1.5% Hydrogen Peroxide

    MILD MINT

    50 Unit Dose Packets 0.34 FL OZ (10 mL) Each
    TOTAL 17 FL OZ (1.06 PT) 502 mL

    PRINCIPAL DISPLAY PANEL - 50 Packet Carton
  • INGREDIENTS AND APPEARANCE
    PEROXYL MOUTH SORE MILD MINT 
    hydrogen peroxide rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0126-0083
    Route of AdministrationBUCCAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Hydrogen Peroxide (UNII: BBX060AN9V) (Hydrogen Peroxide - UNII:BBX060AN9V) Hydrogen Peroxide15 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Sorbitol (UNII: 506T60A25R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Poloxamer 338 (UNII: F75JV2T505)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorBLUE (Light Blue Solution with the Smell of Mint) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0126-0083-7050 in 1 CARTON
    110 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35601/01/2009
    Labeler - Colgate Oral Pharmaceuticals, Inc. (055002195)
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