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NDC 53462-0804-60 QCare Oral Cleansing and Suctioning System, Q4 Details
QCare Oral Cleansing and Suctioning System, Q4
QCare Oral Cleansing and Suctioning System, Q4 is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by Sage Products LLC. The primary component is .
Product Information
NDC | 53462-0804 |
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Product ID | 53462-804_d8a00045-194b-4d0f-e053-2a95a90ad47f |
Associated GPIs | 97500000006400 |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | QCare Oral Cleansing and Suctioning System, Q4 |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | CETYLPYRIDINIUM CHLORIDE and HYDROGEN PEROXIDE |
Product Type | HUMAN OTC DRUG |
Dosage Form | KIT |
Route | n/a |
Active Ingredient Strength | n/a |
Active Ingredient Units | n/a |
Substance Name | n/a |
Labeler Name | Sage Products LLC |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH NOT FINAL |
Application Number | part356 |
Listing Certified Through | 2023-12-31 |
Package
Package Images








NDC 53462-0804-60 (53462080460)
NDC Package Code | 53462-804-60 |
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Billing NDC | 53462080460 |
Package | 1 KIT in 1 KIT (53462-804-60) * 6 PACKET in 1 KIT / 2 g in 1 PACKET * 2 PACKET in 1 KIT / 7 mL in 1 PACKET * 4 PACKET in 1 KIT / 7 mL in 1 PACKET |
Marketing Start Date | 2004-06-30 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL f30104fd-7f9a-4db1-8006-36b5b6d7ddae Details
Drug Facts
USES
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.
SPL UNCLASSIFIED SECTION
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.
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 Handle.
- Clean teeth and oral cavity for approximately one minute.
- To suction, slide switch to ON. When finished, return switch to OFF.
- To clear tubing, rinse with sterile saline or appropriate solution.
- Discard Suction Swab. Reattach Covered Yankauer to Suction Handle.
- 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 Handle.
- Clean teeth and oral cavity for approximately one minute.
- To suction, slide switch to ON. When finished, return switch to OFF.
- To clear tubing, rinse with sterile saline or appropriate solution.
- Discard Toothbrush. Reattach Covered Yankauer to Suction Handle.
- 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 Cather to Suction Handle.
- Suction secretions from the oropharyngeal cavity.
- To suction, slide switch to ON. When finished, return switch to OFF.
- To clear tubing, rinse with sterile saline or appropriate solution.
- Discard Suction Catheter. Reattach Covered Yankauer to Suction Handle.
- Use a 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 practicioner.
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?
INGREDIENTS AND APPEARANCE
QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4
cetylpyridinium chloride and hydrogen peroxide kit |
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QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q8
cetylpyridinium chloride and hydrogen peroxide kit |
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Labeler - Sage Products LLC (054326178) |
Registrant - Sage Products LLC (054326178) |