Label: QCARE ORAL CLEANSING AND SUCTIONING SYSTEM- cetylpyridinium chloride kit
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Contains inactivated NDC Code(s)
NDC Code(s): 53462-462-60, 53462-464-60 - 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 January 29, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DOSAGE FORMS & STRENGTHS
- DOSAGE & ADMINISTRATION
- Drug Facts
- INDICATIONS & USAGE
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
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Directions
Toothette Oral Care Suction Toothbrush
- Before opening, turn package over, burst solution packet with thumbs.
- Peel lid to open.
- 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.
- 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.
Toothette Oral Care Suction Swab
- Before opening, turn package over, burst solution packet with thumbs.
- Peel lid to open.
- 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.
- 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 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 Yankaurer to suction line.
- Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
QCARE ORAL CLEANSING AND SUCTIONING SYSTEM
cetylpyridinium chloride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53462-462 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53462-462-60 1 in 1 KIT; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug 01/11/2016 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 Part 2 12 POUCH 84 mL in 12 Part 1 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 Part 2 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 .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 12 in 1 PACKET 1 7 mL in 1 POUCH; 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 01/11/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/11/2016 QCARE ORAL CLEANSING AND SUCTIONING SYSTEM
cetylpyridinium chloride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53462-464 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53462-464-60 1 in 1 KIT; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug 01/11/2016 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 Part 2 6 POUCH 42 mL in 6 Part 1 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 Part 2 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 .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 6 in 1 PACKET 1 7 mL in 1 POUCH; 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 01/11/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/11/2016 Labeler - Sage Products LLC (054326178) Registrant - Sage Products LLC (054326178) Establishment Name Address ID/FEI Business Operations Sage Products LLC 054326178 MANUFACTURE(53462-464, 53462-375, 53462-462)
