Label: PREVENTION ONCOLOGY MOUTH RINSE- glycerin liquid

  • NDC Code(s): 69951-001-03, 69951-001-16
  • Packager: Prevention Health Sciences, 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 January 10, 2023

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  • Drug Facts

  • Active Ingredients

    Glycerin 4.5%

  • Purpose

    Oral Demulcent

  • Uses

    for temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

  • Warnings

  • DO NOT USE

    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 throat is severe • lasts for more than 2 days • is accompanied or followed by fever, headache, rash, nausea or vomiting • sore mouth symptoms do not improve in 7 days

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children 2 years of age and older: gargle, swish around in the mouth over the affected area for at least one minute and then spit out. Use as needed or as directed by dentist or doctor.

    children under 12 years of age should be supervised in the use of product.

    children under 2: consult with a dentist or doctor.

  • Other information

    keep product away from heat or direct sunlight

    DO NOT USE IF SAFETY SEAL IS BROKEN

  • Inactive ingredients

    citric acid, de-ionized water, disodium EDTA, hydrogen peroxide, menthol, peppermint oil, poloxamer 407, sodium citrate, xylitol, zinc chloride

  • QUESTIONS

    Questions Call 800-473-1205

  • SPL UNCLASSIFIED SECTION

    Formulated and Ditributed by:

    Prevention Health Sciences, Inc.

    Raleigh, IL 62977

    800-473-1205

    PHS Brands

    www.preventionhs.com

  • PRINCIPAL DISPLAY PANEL

    ALCOHOL FREE

    PREVENTION MOUTH RINSE

    Formulated for Oncology Patients

    √ Soothes & Protects Oral Mucosa

    √ Provides Temporary Oral Pain Relief

    √ Hydrating Formula

    Soothing Mint

    NET. 16 FL OZ (1 PT) 473 ML

    label

  • INGREDIENTS AND APPEARANCE
    PREVENTION ONCOLOGY MOUTH RINSE 
    glycerin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69951-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN4.5 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    MENTHOL (UNII: L7T10EIP3A)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69951-001-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/10/2023
    2NDC:69951-001-0395 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/10/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/10/2023
    Labeler - Prevention Health Sciences, Inc. (968930540)
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