Label: QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4- cetylpyridinium chloride and hydrogen peroxide kit
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Contains inactivated NDC Code(s)
NDC Code(s): 53462-075-60, 53462-275-60, 53462-424-60 - Packager: Sage Products, 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 June 29, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Use
- INDICATIONS & USAGE
- Warnings
- KEEP OUT OF REACH OF CHILDREN
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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
- Drug Facts
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
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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
- Questions?
- QCare Oral Cleansing & Suctioning System, q4 Reorder#6424
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INGREDIENTS AND APPEARANCE
QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4
cetylpyridinium chloride and hydrogen peroxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53462-424 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53462-424-60 1 in 1 KIT; Type 1: Convenience Kit of Co-Package 06/30/2008 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 4 PACKET 28 mL Part 2 2 PACKET 14 mL Part 3 6 PACKET 12 g Part 4 1 Part 1 of 4 PEROX-A-MINT SOLUTION
hydrogen peroxide mouthwashProduct Information Item Code (Source) NDC:53462-075 Route of Administration BUCCAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 15 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 4 in 1 KIT 1 NDC:53462-075-60 7 mL in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 05/21/1998 Part 2 of 4 ANTIPLAQUE SOLUTION
cetylpyridinium chloride mouthwashProduct Information Item Code (Source) NDC:53462-275 Route of Administration BUCCAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 2 in 1 KIT 1 NDC:53462-275-60 7 mL in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/09/2009 Part 3 of 4 MOUTH MOISTURIZER
other oral hygiene productsProduct Information Other Ingredients Ingredient Kind Ingredient Name Quantity INGR COCONUT OIL (UNII: Q9L0O73W7L) INGR XYLITOL (UNII: VCQ006KQ1E) INGR CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR SPEARMINT OIL (UNII: C3M81465G5) INGR WATER (UNII: 059QF0KO0R) INGR CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) INGR POLYSORBATE 20 (UNII: 7T1F30V5YH) INGR POLYSORBATE 80 (UNII: 6OZP39ZG8H) INGR POTASSIUM SORBATE (UNII: 1VPU26JZZ4) INGR CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 6 in 1 KIT 1 2 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic Part 4 of 4 SODIUM BICARBONATE
other oral hygiene productsProduct Information Other Ingredients Ingredient Kind Ingredient Name Quantity INGR SODIUM BICARBONATE (UNII: 8MDF5V39QO) INGR CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) INGR SODIUM LAURYL SULFATE (UNII: 368GB5141J) INGR SODIUM BENZOATE (UNII: OJ245FE5EU) INGR WATER (UNII: 059QF0KO0R) INGR SACCHARIN SODIUM (UNII: SB8ZUX40TY) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 06/30/2008 Labeler - Sage Products, LLC (054326178)