Label: SARINA ANTISEPTIC- chlorhexidine digluconate liquid

  • NDC Code(s): 90106-003-01
  • Packager: Sarina Accessories, LLC
  • 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 25, 2020

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  • Active ingredients

    Cetylpyridinium Chloride 0.1%.

  • Purpose

    Antiplaque

  • Use

    Helps reduce plaque that leads to

    • ginivitis
    • bleeding gums
  • Warnings

    Stop use and see your dentist immediately if

    • gingivitis, bleeding, or redness persists for more than 2 weeks
    • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing space between the teeth.

    These may be signs or symptoms of periodontitis, a serious form of gum disease.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under 6 years of age.

    If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    adults and children 12 years of age and older

    vigorously swish 20 milliliters of rinse between teeth twice a day for 30 seconds then spit out. Do not swallow the rinse
    children 6 to 12 years of agesupervise use
    children under 6 years of agedo not use

  • Other information

    • not intended to replace brushing or flossing
    • store at room temperature (59°-77°F).
    • cold weather may cloud this product, but will not affect its antiseptic properties.

  • Inactive ingredients

    Water, Alcohol, PEG-60 Hydrogenated Castor Oil，Glycerin，Fragrance，Sodium Benzoate，Mentholum，Sodium Saccharin，Citric Acid，FD&C Blue No.1

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    SARINA  ANTISEPTIC
    chlorhexidine digluconate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90106-003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE1 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ALCOHOL (UNII: 3K9958V90M)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    MENTHOL (UNII: L7T10EIP3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:90106-003-0190 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35608/25/2020
    Labeler - Sarina Accessories, LLC (787043145)
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