QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]

QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]
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NDC 53462-075-60, 53462-275-60, 53462-424-60
Set ID 567bf599-4958-91c7-5c01-9c38a0d2da52
Category HUMAN OTC DRUG LABEL
Packager Sage Products, LLC
Generic Name
Product Class
Product Number
Application Number PART356
  • Drug Facts

    Suction Swab with Perox-A-Mint® Solution 
    Active Ingredient Purpose
     PEROX-A-MINT
     Hydrogen peroxide 1.5% Oral debriding agent

  • Use

    • Aids in the removal of secretions and debris.
  • 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 of worsens.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.
    If more than used for debriding is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Before opening, turn package over, burst solution packet with thumbs.
    • Peel lid to open.
    • Remove Mouth Moisturizer and Applicator Swab.
    • Attach Suction Swab to suction line.
    • Clean teeth and oral cavity for approximately one minute.
    • To suction, place thumb over port.
    • To clear tubing, rinse with sterile saline or appropriate solution.
    • Discard Suction Swab. Reattach Covered Yankauer to suction line.
    • Place Mouth Moisturizer on Applicator Swab.
    • Apply as needed to lips and inside mouth.
    • Use up to 4 times daily or as directed by a dentist or doctor.
    • Children under 12 years of age: supervise use.
    • 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.
  • DOSAGE & ADMINISTRATION

  • Inactive ingredients

    Water, menthol flavor, polysorbate 80, phosphoric acid, sodium saccharin, Blue 1 (CI 42090), Yellow 6 (CI 15985)

  • Drug Facts

     Suction Toothbrush with Antiplaque Solution
    Active Ingredient Purpose
     ANTIPLAQUE
     Cetylpyridinium chloride .05% Antigingivitis/antiplaque

  • Uses

    Suction Toothbrush with Antiplaque Solution:

    • Aids in the removal and prevention of plaque that leads to gingivitis.

    Oropharyneal Suction Catheter packages:

    • Aids in the removal of secretions from the oropharyngeal cavity only.
  • Warnings

    Stop use and ask a dentist 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 spacing 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 the reach of children under 6 years of age.
    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Suction Toothbrush with Antiplaque Solution:

    • Before opening, turn package over, burst solution packet with thumbs.
    • Peel lid to open.
    • Remove Mouth Moisturizer and Applicator Swab.
    • Attach Toothbrush to suction line.
    • Clean teeth and oral cavity for approximately one minute.
    • To suction, place thumb over port.
    • To clear tubing, rinse with sterile saline or appropriate solution.
    • Discard Toothbrush. Reattach Covered Yankauer to suction line.
    • Place Mouth Moisturizer on Applicator Swab.
    • Apply as needed to lips and inside mouth.
    • Adults and children 12 years of age and older: use two times daily or as directed by a dentist. Do not swallow the solution.
    • Children ages 6 to 12 years: supervise use.
    • Children under 6 years of age: do not use.
    • 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.

    Oropharyngeal Suction Catheter:

    • Peel lid to open.
    • Attach Suction Catheter to suction line.
    • Suction secretions from the oropharyngeal cavity.
    • To suction, place thumb over port.
    • To clear tubing, rinse with sterile saline or appropriate solution.
    • Discard Suction Catheter. Reattach Covered Yankauer to suction line.
    • Use bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.

    Caution

    • Federal (U.S.A.) law restricts this device to sale by or on the order of a physician or licensed practitioner.
  • Inactive Ingredients

    Suction Toothbrush with Antiplaque Solution:

    Water, sorbitol, peppermint flavor, potassium sorbate, polysorbate 80, polysorbate 20, citric acid, Blue 1 (CI42090).

  • Questions?

    Call toll-free 800–323–2220

    Manufactured for Sage Products, LLC Cary, IL

    NOT MADE WITH NATURAL RUBBER LATEX. FOR SINGLE USE ONLY. MADE IN U.S.A.

  • QCare Oral Cleansing & Suctioning System, q4 Reorder#6424

    Perox-A-Mint SolutionAntiplaque SolutionQCare 6424QCare 6424 FilmQCare 6424 Drug Facts

  • INGREDIENTS AND APPEARANCE
    QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 
    cetylpyridinium chloride and hydrogen peroxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-424
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53462-424-601 in 1 KIT; Type 1: Convenience Kit of Co-Package06/30/2008
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 14 PACKET 28 mL
    Part 22 PACKET 14 mL
    Part 36 PACKET 12 g
    Part 4
    Part 1 of 4
    PEROX-A-MINT SOLUTION 
    hydrogen peroxide mouthwash
    Product Information
    Item Code (Source)NDC:53462-075
    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)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14 in 1 KIT
    1NDC:53462-075-607 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 finalpart35605/21/1998
    Part 2 of 4
    ANTIPLAQUE SOLUTION 
    cetylpyridinium chloride mouthwash
    Product Information
    Item Code (Source)NDC:53462-275
    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
    12 in 1 KIT
    1NDC:53462-275-607 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 finalpart35601/09/2009
    Part 3 of 4
    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)  
    INGRSPEARMINT OIL (UNII: C3M81465G5)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRCARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRPOLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    INGRCETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    16 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 4 of 4
    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 finalpart35606/30/2008
    Labeler - Sage Products, LLC (054326178)

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