Label: SUCTION TOOTHBRUSHES- cetylpyridinium chloride kit

  • Category: HUMAN OTC DRUG LABEL

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 April 26, 2018

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  • Drug Facts

     Active Ingredient Purpose
    Antiseptic Oral Rinse
    .05% Cetylpyridinium chlorideOral Antiseptic

  • Uses

    • Helps reduce the chance of infection in minor oral irritation.
    • Aids in the removal of debris, dental plaque and secretions.
  • INDICATIONS & USAGE

  • Warnings

    Stop use and ask a doctor if:


    • Sore mouth symptoms do not improve in 7 days.
    • Swelling, rash or fever develops.
    • Irritation, pain or redness persists or worsens.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If more than used for antisepsis is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

  • Directions

    • Before opening, turn package over, burst solution packet with thumbs.
    • Peel lid to open. 
    • Remove toothbrush and attach to suction line.  
    • Clean teeth and oral cavity for approximately one minute.
    • To suction, place thumb over port.
    • Repeat cleaning with other toothbrush as needed.
    • Discard after use.
    • Apply Mouth Moisturizer as needed.
    • Use up to 4 times daily, or as directed by a dentist or doctor.
    • Children under 12 years of age should be supervised in the use of this product.
    • Children under 3 years of age, consult a dentist or doctor.
    • Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.
    • Ensure foam is intact after use. If not, remove any particles from oral cavity.
  • Inactive Ingredients

    Water, sorbitol, peppermint flavor, potssium sorbate, polysorbate 80, polysorbate 20, citric acid, FD&C Blue #1.

  • Questions

    Call toll free 800-323-2220

  • SPL UNCLASSIFIED SECTION

  • Suction Toothbrushes

    Suction Toothbrushes 6173

  • Antispetic Oral Rinse

    Antiseptic Oral Rinse Packet

  • INGREDIENTS AND APPEARANCE
    SUCTION TOOTHBRUSHES 
    cetylpyridinium chloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-273
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53462-273-601 in 1 KIT; Type 1: Convenience Kit of Co-Package06/30/2006
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 PACKET 7 mL
    Part 21 PACKET 2 g
    Part 3
    Part 1 of 3
    ANTISEPTIC ORAL RINSE 
    cetylpyridinium chloride mouthwash
    Product Information
    Item Code (Source)NDC:53462-175
    Route of AdministrationBUCCAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 KIT
    1NDC:53462-175-607 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/21/2000
    Part 2 of 3
    MOUTH MOISTURIZER 
    other oral hygiene products
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRCOCONUT OIL (UNII: Q9L0O73W7L)  
    INGRXYLITOL (UNII: VCQ006KQ1E)  
    INGRCARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRPOLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    INGRCETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    INGRCARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    INGRSPEARMINT OIL (UNII: C3M81465G5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 KIT
    12 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Part 3 of 3
    SODIUM BICARBONATE 
    other oral hygiene products
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRSODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    INGRCARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    INGRSODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRSACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/30/2006
    Labeler - Sage Products LLC (054326178)
    Registrant - Sage Products LLC (054326178)