NDC | 53462-504-60 |
Set ID | 207b8fdf-4f03-69b8-4621-b8054b7ae6a6 |
Category | HUMAN OTC DRUG LABEL |
Packager | Sage Products LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART356 |
- 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)