Label: FAMILY WELLNESS TOTAL HEALTH- cetylpyridinium chloride rinse

  • 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 August 23, 2021

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients
    Cetylpyridinium chloride 0.07%

  • PURPOSE

    Purpose

    Antigingivitis, Antiplaque

  • INDICATIONS & USAGE

    Usehelps control plaque that leads to gingivitis

  • WARNINGS

    Warnings

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 6 years of age and older: use twice a day after brushing your teeth with toothpaste
    • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
    • do not swallow the rinse
    • do not eat or drink for 30 minutes after rinsing
    • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
    • supervise children as necessary until capable of using without supervision
    • children under 6 years of age: consult a dentist or doctor
  • INACTIVE INGREDIENT

    Inactive ingredients water, glycerin, flavor, poloxamer 407, sodium saccharin and/or sucralose, citric acid, blue 1.

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: Midwood Brands, LLC 500 Volvo Parkway, Chesapeake, VA 23320

    Made in Canada

    * This product is not manufactured or distributed by Proctor and Gamble, distributor of Crest®.

  • PRINCIPAL DISPLAY PANEL

    COMPARE TO CREST® PRO HEALTH*

    FAMILY wellness™

    ALCOHOL FREE

    TOTAL HEALTH

    MOUTH RINSE

    MULTI-ACTION ANTISEPTIC

    • Kills Germs that Cause Bad Breath, Plaque and Gingivitis
    • Freshens Breath
    • Helps Keep Mouth Feeling Clean
    • No Burn of Alcohol

    33.8 FL OZ (1000 mL)

    Total Health Mouth Rinse

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS  TOTAL HEALTH
    cetylpyridinium chloride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-234
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.07 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-234-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/20/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/20/2019
    Labeler - Family Dollar Services Inc. (024472631)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!