Label: QCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM- 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 January 17, 2019

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  • Drug Facts

    Suction Swab, Petite Size, with Antiseptic Oral Rinse/Suction Toothbrush, Petite Size, with Antiseptic Oral Rinse
    Active Ingredient:
    ANTISEPTIC ORAL RINSE:
    Purpose
    Cetylpyridinium chloride .05%Antiseptic Rinse
  • Uses

    Suction Swab with Antiseptic Oral Rinse

    • Aids in the removal of secretions and debris and helps reduce the chance of infection in minor oral irritation.

    Suction Toothbrush with Antiseptic Oral Rinse

    • Aids in the removal of dental plaque, secretions, and debris; helps reduce the chance of infection in minor oral irritation.

    Oropharyngeal Suction Catheter

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

    Suction Swab with Antiseptic Oral Rinse

    • 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 Antiseptic Oral Rinse

    • Before opening, turn package over, burst solution packet with thumbs.
    • Peel lid to open.
    • Remove Mouth Moisturizer and Applicator Swab.
    • Attach Suction 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.
    • 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.

    Oropharyngeal Suction Catheter

    • Peel lid to open.
    • Attach Suction Catheter to suction line.
    • 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 a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.

    CAUTION:

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

    Water, sorbitol, mentha piperita (peppermint) extract, potassium sorbate, polysorbate 80, polysorbate 20, citric acid, Blue 1 (CI 42090)

  • Questions?

    Call toll-free 800-323-2220.

  • Mouth Moisturizer ingredients*

    Water, cocos nucifera (coconut) oil, xylitol, flavor, cellulose gum, tocopheryl acetate (vitamin E), mentha veridis (spearmint) leaf oil, carbomer, polysorbate 20, polysorbate 80, potassium sorbate, cetylpyridinium chloride

    * Manufactured for Sage Products LLC • Cary, IL

    www.sageproducts.com/patents

    NOT MADE WITH NATURAL RUBBER LATEX • FOR SINGLE USE ONLY • MADE IN USA

  • QCare Petite Size Oral Cleansing and Suctioning System

    QCare 6714QCare 6714 filmQCare 6714 Drug Facts

  • Antiseptic Oral Rinse Solution

    Antiseptic Oral Solution

  • INGREDIENTS AND APPEARANCE
    QCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM 
    cetylpyridinium chloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-714
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53462-714-601 in 1 KIT; Type 1: Convenience Kit of Co-Package04/02/2013
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 16 PACKET 42 mL  in 6 
    Part 26 PACKET 12 g  in 6 
    Part 1 of 2
    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
    SORBITOL (UNII: 506T60A25R)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    16 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 finalpart35605/21/1998
    Part 2 of 2
    MOUTH MOISTURIZER 
    other oral hygiene products emulsion
    Product Information
    Route of AdministrationBUCCAL
    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)  
    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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35604/02/2013
    Labeler - Sage Products, LLC (054326178)