Qcare Oral Cleansing And Suctioning System, Q4
Cetylpyridinium Chloride And Hydrogen Peroxide
Sage Products Llc
Human Otc Drug
NDC 53462-804Qcare Oral Cleansing And Suctioning System, Q4 also known as Cetylpyridinium Chloride And Hydrogen Peroxide is a human otc drug labeled by 'Sage Products Llc'. National Drug Code (NDC) number for Qcare Oral Cleansing And Suctioning System, Q4 is 53462-804. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Qcare Oral Cleansing And Suctioning System, Q4 drug includes . The currest status of Qcare Oral Cleansing And Suctioning System, Q4 drug is Active.
Drug Information:
| Drug NDC: | 53462-804 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Qcare Oral Cleansing And Suctioning System, Q4 |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Cetylpyridinium Chloride And Hydrogen Peroxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Sage Products Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 30 Jun, 2004 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part356 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Sage Products LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 358975
1251617
1866540
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 53462-804-60 | 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 | 30 Jun, 2004 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
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.
Product Elements:
Qcare oral cleansing and suctioning system, q4 cetylpyridinium chloride and hydrogen peroxide perox-a-mint solution hydrogen peroxide water polysorbate 80 phosphoric acid saccharin sodium fd&c blue no. 1 fd&c yellow no. 6 hydrogen peroxide hydrogen peroxide antiplaque solution cetylpyridinium chloride sorbitol potassium sorbate polysorbate 80 polysorbate 20 fd&c blue no. 1 water citric acid monohydrate cetylpyridinium chloride cetylpyridinium sodium bicarbonate sodium bicarbonate carboxymethylcellulose sodium sodium lauryl sulfate sodium benzoate water saccharin sodium mouth moisturizer cetylpyridinium chloride carbomer homopolymer type b (allyl pentaerythritol crosslinked) coconut oil xylitol carboxymethylcellulose sodium .alpha.-tocopherol acetate water polysorbate 20 polysorbate 80 potassium sorbate qcare oral cleansing and suctioning system, q8 cetylpyridinium chloride and hydrogen peroxide perox-a-mint solution hydrogen peroxide water polysorbate 80 phosphoric acid saccharin sodium fd&c blue no. 1 fd&c yellow no. 6 hydrogen peroxide hydrogen peroxide antiplaque solution cetylpyridinium chloride sorbitol potassium sorbate polysorbate 80 polysorbate 20 fd&c blue no. 1 water citric acid monohydrate cetylpyridinium chloride cetylpyridinium sodium bicarbonate sodium bicarbonate carboxymethylcellulose sodium sodium lauryl sulfate sodium benzoate water saccharin sodium mouth moisturizer carboxymethylcellulose sodium .alpha.-tocopherol acetate water polysorbate 20 polysorbate 80 potassium sorbate cetylpyridinium chloride carbomer homopolymer type b (allyl pentaerythritol crosslinked) coconut oil xylitol
Indications and Usage:
Warnings:
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.
When Using:
Uses suction swab with perox-a-mint: aids in the removal of secretions and debris. suction toothbrush with antiplaque solution: aids in the removal and prevention of plaque that leads to gingivitis. oropharyngeal suction catheter: aids in the removal of secretions from the oropharyngeal cavity only.
Dosage and Administration:
Package Label Principal Display Panel:
Qcare oral cleansing and suctioning system, q4 qcare 6804 qcare film 6804 qcare drug facts 6804
Qcare oral cleansing and suctioning system, q8 qcare 6808 qcare film 6808 qcare drug facts 6808
Antiplaque solution, perox-a-mint antiplaque solution perox-a-mint
Further Questions:
Questions? call toll-free 800â323â2220 manufactured for sage products llc cary, il not made with natural rubber latex. for single use only. made in u.s.a.