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): 53462-504-60 - 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 August 20, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- USES
- INDICATIONS & USAGE
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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.
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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
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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.
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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?
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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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:53462-504 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53462-504-60 1 in 1 KIT Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 POUCH 7 mL Part 2 1 POUCH 7 mL Part 1 of 2 TOOTHETE ORAL CARE SUCTION SWAB WITH PEROX-A-MINT SOLUTION
hydrogen peroxide mouthwashProduct Information 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 [iU] 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 1 in 1 PACKAGE 1 2 in 1 PACKET 1 7 mL in 1 POUCH 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 2 SUCTION TOOTHBRUSH WITH ANTIPLAQUE SOLUTION
cetylpyridinium chloride mouthwashProduct Information Route of Administration BUCCAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE .5 [iU] 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 1 in 1 PACKAGE 1 2 in 1 PACKET 1 7 mL in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 05/21/1998 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 05/21/1998 Labeler - Sage Products LLC (054326178) Registrant - Sage Products LLC (054326178) Establishment Name Address ID/FEI Business Operations ChemRite CoPac, Inc. 623776502 MANUFACTURE(53462-504) Establishment Name Address ID/FEI Business Operations Sage Products LLC 054326178 MANUFACTURE(53462-504)
