Oraqix

Oraqix is an FDA-registered drug product whose active ingredient is LIDOCAINE AND PRILOCAINE. It is labelled by Dentsply Pharmaceutical taken by periodontal and marketed as a human prescription drug product. Identifiers on file: NDC 66312-110, application NDA021451, label effective 20260421. It is one of 4 FDA drug label records sharing the active ingredient LIDOCAINE AND PRILOCAINE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing LIDOCAINE AND PRILOCAINE are most often described in connection with: oraqix amide, local anesthetic, require localized, anesthesia periodontal, root planing. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Oraqix is an amide local anesthetic indicated for adults who require localized anesthesia in periodontal pockets during scaling and/or root planing. Oraqix is an amide local anesthetic indicated for adults who require localized anesthesia in periodontal pockets during scaling and/or root planing. ( 1 )

2 DOSAGE AND ADMINISTRATION Use the included blunt-tipped applicator and the dispenser, which is sold separately, to apply gel to gingival margins and periodontal pockets. ( 2 ) May be reapplied as needed up to a maximum of 5 cartridges per treatment session.( 2 ) 2.1 General Dosing Information DO NOT INJECT [see Warnings and Precautions (5.2) ] Apply Oraqix on the gingival margin around the selected teeth using the blunt-tipped applicator included in the package and the dispenser, which is sold separately. Wait 30 seconds, and then fill the periodontal pockets with Oraqix using the blunt-tipped applicator until the gel becomes visible at the gingival margin. Wait another 30 seconds before starting treatment. A longer waiting time does not enhance the anesthesia. Anesthetic effect, as assessed by probing of pocket depths, has a duration of approximately 20 minutes (individual overall range 14–31 minutes). If the anesthesia starts to wear off, Oraqix may be re-applied if needed. Typically, one cartridge (1.7g) or less of Oraqix will be sufficient for one quadrant of the dentition. When administered, Oraqix should be a liquid. If it has formed a gel, it should be placed in a refrigerator (do not freeze) until it becomes a liquid again. When in the liquid state, the air bubble visible in the cartridge will move if the cartridge is tilted. 2.2 Maximum Recommended Dosage The maximum recommended dose of Oraqix at one treatment session is 5 cartridges, i.e., 8.5g gel.

4 CONTRAINDICATIONS Oraqix is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to any other component of the product. A history of hypersensitivity to local anesthetics of the amide type ( 4 ) A history of hypersensitivity to any component of the product ( 4 )

6 ADVERSE REACTIONS Most common adverse reactions (incidence >15%) are application site reactions including pain, soreness, irritation, numbness, ulcerations, vesicles, edema, abscess and/or redness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact DENTSPLY Pharmaceutical at 1-800-989- 8826 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug can not be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice . Although no major differences in adverse events between Oraqix and placebo-treated subjects were observed, all patients in the placebo-controlled studies received either Oraqix or a placebo gel (consisting of the vehicle in Oraqix without lidocaine or prilocaine). Therefore, it is not possible to determine if adverse events in each treatment group were attributable to the inactive ingredients comprising the Oraqix or vehicle or if adverse event rates were higher than expected background rates. Therefore, a causal relationship between the reported adverse reactions and Oraqix could neither be established nor ruled out. Following SRP treatment with Oraqix in 391 patients, the most frequent adverse events were local reactions in the oral cavity (see following table ). These events, which occurred in approximately 15% of patients, included pain, soreness, irritation, numbness, vesicles, ulcerations, edema and/or redness in the treated area. Of the 391 patients treated with Oraqix, five developed ulcerative lesions and two developed vesicles of mild to moderate severity near the site of SRP. In addition, ulcerative lesions in or near the treated area were also reported for three out of 168 patients who received placebo. Other symptoms reported in more than one patient were headache, taste perversion, nausea, fatigue, flu, respiratory infection, musculoskeletal pain and accident/injury. Table 1. Number (percent) of patients with adverse events occurring in more than one patient in any of the treatment groups. Each patient is counted only once per adverse event. The occurrence in a single patient is included in this table if the same symptom has been seen in at least one patient in another group. System Organ Class PreferredTerm Oraqix gel in a cross-over study, 170 subjects received either Oraqix or lidocaine injection 2% in each test period (N=391)n (%) Placebo gel (N=168)n (%) Lidocaine injection (N=170)n (%) Muscular-Skeletal System Disorders Myalgia 1(0) 2(1) Arthralgia and/or Arthropathy 1(0) 1(1) Central & Peripheral Nervous System Disorders Headache 8(2) 3(2) 5(3) Dizziness 1(0) 1(1) 1(1) Special Senses Other, Disorders Taste Perversion includes complaints of bad or bitter taste lasting for up to 4 hours after administration of Oraqix 8(2) 1(1) Gastro-Intestinal System Disorders Nausea 3(1) 1(1) Respiratory System Disorders Respiratory Infection 2(1) 1(1) Rhinitis 2(1) Body as a whole-General Disorders Accident and/or Injury 2(1) 2(1) Fatigue 3(1) 2(1) Flu-Like Disorder 2(1) Pain (remote from application site) 1(0) 1(1) 1(1) Application Site Disorders i.e. symptoms in the oral cavity Anesthesia Local 2(1) Application Site Reaction includes pain, soreness, irritation, numbness, ulcerations, vesicles, edema, abscess and/or redness in the treated area 52(13) 20(12)

FDA lists 4 drug label records with LIDOCAINE AND PRILOCAINE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Oraqix used for?
1 INDICATIONS AND USAGE Oraqix is an amide local anesthetic indicated for adults who require localized anesthesia in periodontal pockets during scaling and/or root planing. Oraqix is an amide local anesthetic indicated for adults who require localized anesthesia in periodontal pockets during scaling and/or root planing. ( 1 )

Who makes Oraqix?
Dentsply Pharmaceutical is the labeler of record for Oraqix. 4 FDA label records share the active ingredient LIDOCAINE AND PRILOCAINE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Oraqix come in?
administered by periodontal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Oraqix prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing LIDOCAINE AND PRILOCAINE?
Yes. 4 FDA drug label records list LIDOCAINE AND PRILOCAINE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Oraqix been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.