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 53462-504-60
Set ID 207b8fdf-4f03-69b8-4621-b8054b7ae6a6
Category HUMAN OTC DRUG LABEL
Packager Sage Products LLC
Generic Name
Product Class
Product Number
Application Number PART356
  • Drug Facts

    Active Ingredient: PEROX-A-MINT:Purpose
    Hydrogen Peroxide 1.5%Oral Debriding Agent
    Active Ingredient: ANTIPLAQUE*:Purpose
    Cetylpyridinium chloride .05%Antigingivitis/antiplaque
  • USES

    Suction Swab with Perox-A-Mint Solution:

    • Aids in the removal of secretions and debris.

    Suction Toothbrush with Antiplaque Solution:

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

  • WARNINGS

    Suction Swab with Perox-A-Mint Solution:

    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.

    Suction Toothbrush with Antiplaque Solution:

    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

    Suction Swab with Perox-A-Mint Solution:
    Keep out of reach of children.
    If more than used for debriding is accidentally swallowed, get medical help or contact a Poison Control Center right away.

    Suction Toothbrush with Antiplaque Solution:
    Keep out of 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.

  • DOSAGE & ADMINISTRATION

  • DIRECTIONS

    Suction Swab with Perox-A-Mint Solution:

    • 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.

    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.
  • Inactive Ingredients

    Suction Swab with Perox-A-Mint Solution:
    Water, menthol flavor, polysorbate 80, phosphoric acid, sodium saccharin, Blue 1 (CI 42090), Yellow 6 (CI 15985)

    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

  • PRINCIPAL DISPLAY PANEL

    Q·Care® Oral Cleansing and Suctioning System

    R4699B_6504_bag1
  • PRINCIPAL DISPLAY PANEL

    Q·Care® Oral Cleansing and Suctioning System Label

    R6037_6504_overlabel2
  • PRINCIPAL DISPLAY PANEL

    Q-Care® Oral Cleansing and Suctioning System, q4°

    R5427_top_web_film_6504
  • 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:53462-504
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53462-504-601 in 1 KIT
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 POUCH 7 mL
    Part 21 POUCH 7 mL
    Part 1 of 2
    TOOTHETE ORAL CARE SUCTION SWAB WITH PEROX-A-MINT SOLUTION 
    hydrogen peroxide mouthwash
    Product Information
    Route of AdministrationBUCCAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE15 [iU]  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
    11 in 1 PACKAGE
    12 in 1 PACKET
    17 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35605/21/1998
    Part 2 of 2
    SUCTION TOOTHBRUSH WITH ANTIPLAQUE SOLUTION 
    cetylpyridinium chloride mouthwash
    Product Information
    Route of AdministrationBUCCAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE.5 [iU]  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 PACKAGE
    12 in 1 PACKET
    17 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35605/21/1998
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35605/21/1998
    Labeler - Sage Products LLC (054326178)
    Registrant - Sage Products LLC (054326178)
    Establishment
    NameAddressID/FEIBusiness Operations
    ChemRite CoPac, Inc.623776502MANUFACTURE(53462-504)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sage Products LLC054326178MANUFACTURE(53462-504)

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