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| Product NDC Code | 10733-175 | ||||
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| Drug Name | Topicale xtra |
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| Type | Brand | ||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 238910, 864735 |
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| Application Number | part356 | ||||
| Labeler Name | Medical Products Laboratories, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Benzocaine 20%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Do not use more than directed. Adults and children 12 years or older - Apply to the affected area. Allow to remain in place at least one minute and the spit out. Use up to 4 times daily or as directed by a dentist or doctor. Children 2-12 years of age - Should be supervised in the use of the product. Children under 2 years of age - Do not use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Benzalkonium Chloride (as a preservative), Carbomers, FD&C Blue Dye # 1, FD&C Yellow Dye # 5, Flavorings, Polyethylene Glycol, Purified Water, Saccharin Sodium
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.For the temporary relief of minor pain and irritation associated with minor injury of the mouth and gums, canker sores, minor dental procedures, minor irritation of the mouth and gums caused by dentures or orthodontic appliances
Purpose
Information about the drug product’s indications for use.Oral Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Topicale Xtra Benzocaine FD&C BLUE NO. 1 WATER SACCHARIN SODIUM CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) POLYETHYLENE GLYCOL 400 FD&C YELLOW NO. 5 BENZOCAINE BENZOCAINE BENZALKONIUM CHLORIDE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Package Label Package Carton
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Stop use and ask a doctor 1. If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, swelling, rash, nausea or vomiting 2. If sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens
Information for owners or caregivers
Information for owners or caregiversPeel for Drug Facts NDC 10733-175-01 Premier Topicale Xtra Topical Anesthetic Gel Benzocaine, 20 % REF 9007153 Mint Freeze 28.35g (1 o.z.) For Topical Use only - Not for Injection Contains: 20 % Benzocaine in a specially designed glycol base Made in U.S.A. premierdentalco.com Manufactured for: Premier® Dental Products Company, 1710 Romano Drive, Plymouth Meeting, PA 19462 U.S.A. Mfg: Medical Products Laboratories, Inc. 9990 Global Road Philadelphia, PA 19115 U.S.A. 1120048 MPL Rev5 . 2000265(00) Questions or Comments? 888.670.6100 or 610.239.6000 M-Th: 7:30a.m. - 5:30p.m., F: 7:30a.m. - 4:00p.m. EST To obtain an SDS, contact Customer Service Department or visit premierdentalco.com.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.In case of accidental overdose, get medical help or contact a Poison Control Centre immediately.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Do not use if imprinted seal under cap is broken or missing Store at 68º to 77º F (20º - 25º C)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Methemoglobinemia warning Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops pale, grey or blue colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or light headedness, fatigue or lack of energy. Contraindications: Do not use in large quantities or over large areas of body Do not use for Teething Do not use in children under 2 years of age Allergy Alert: Do not use if you have a history of allergy to local anesthetics such as benzocaine, butacaine, procaine or other "caine" anesthetics When using this product Avoid contact with eyes In case of accidental overdose, get medical help or contact a Poison Control Centre immediately. Stop use and ask a doctor 1. If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, swelling, rash, nausea or vomiting 2. If sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API