Label: QCARE ORAL CLEANSING AND SUCTIONING SYSTEM COMPATIBLE WITH 0.12% CHLORHEXIDINE GLUCONATE (CHG) ORAL RINSE- cetylpyridinium chloride kit
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Contains inactivated NDC Code(s)
NDC Code(s): 53462-994-60 - Packager: Sage Products LLC
- 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 October 23, 2019
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- Official Label (Printer Friendly)
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Drug Facts
Suction Swab with Antiseptic Oral Rinse Active Ingredient:
Corinz™ Antiseptic Cleansing and Moisturizing Oral Rinse:
Cetylpyridinium chloride 0.05%
Purpose
Antiseptic Rinse*Compatible for use with 0.12% Chlorhexidine Gluconate (CHG) oral rinse, tested for use up to five minutes.
NOTE: The following Uses and Directions refer to the Suction Toothbrush and Swab. For Warnings, Uses and Directions specific to the CHG rinse including use in children under 18 years of age, refer to that product’s package insert and labeling. -
Uses
Suction Swab with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse
- Aids in the removal of secretions and debris and helps reduce the chance of infection in minor oral irritation.
Suction Toothbrush CHG compatible*
- Aids in the removal of dental plaque, debris and secretions.
Oropharyngeal Suction Catheter Non-sterile
- Aids in the removal of secretions from the oropharyngeal cavity only.
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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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 CHG compatible*- Peel lid to open.
- Remove Suction Toothbrush and attach to suction line.
- When using with a cleansing solution, refer to the product packaging for indications, instructions and warnings.
- To suctions, place thumb over port.
- To clear tubing, rinse with sterile saline or appropriate solution.
- Discard Suction Toothbrush. Reattach Covered Yankauer to suction line.
- Use Swab for additional cleansing as needed.
- Use two 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 Non-sterile- 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 a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.
- Oropharyngeal Suction Catheter Non-sterile
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?
- SPL UNCLASSIFIED SECTION
- QCare Oral Cleansing & Suctioning System compatible with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse
- Corinz Label
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INGREDIENTS AND APPEARANCE
QCARE ORAL CLEANSING AND SUCTIONING SYSTEM COMPATIBLE WITH 0.12% CHLORHEXIDINE GLUCONATE (CHG) ORAL RINSE
cetylpyridinium chloride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53462-994 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53462-994-60 1 in 1 KIT; Type 1: Convenience Kit of Co-Package 11/16/2016 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 4 PACKET 28 mL in 2 Part 2 1 Part 1 of 2 CORINZ
cetylpyridinium chloride rinseProduct Information Item Code (Source) NDC:53462-375 Route of Administration ORAL 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) GLYCERIN (UNII: PDC6A3C0OX) XYLITOL (UNII: VCQ006KQ1E) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POLYSORBATE 20 (UNII: 7T1F30V5YH) POLYSORBATE 80 (UNII: 6OZP39ZG8H) HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SACCHARIN SODIUM (UNII: SB8ZUX40TY) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4 in 1 PACKET 1 7 mL in 1 PACKET; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/11/2016 Part 2 of 2 SODIUM BICARBONATE
other oral hygiene products powderProduct Information Route of Administration BUCCAL 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 11/16/2016 Labeler - Sage Products LLC (054326178) Registrant - Sage Products LLC (054326178) Establishment Name Address ID/FEI Business Operations Sage Products LLC 054326178 manufacture(53462-994, 53462-375)