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| Product NDC Code | 72751-0302 | ||||
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| Drug Name | Zilactin-b |
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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 | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 198488, 1542803 |
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| Application Number | part356 | ||||
| Labeler Name | Applied 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.Active ingredient Benzocaine 10%
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.Directions adults and children 2 years and older Dry affected area. Apply a thin coat of gel with cotton swab or clean finger up to 4 times daily. Allow to dry 30-60 seconds. children under 12 years adult supervision should be given in the use of this product children under 2 years do not use, consult a physician or dentist
| adults and children 2 years and older | Dry affected area. Apply a thin coat of gel with cotton swab or clean finger up to 4 times daily. Allow to dry 30-60 seconds. |
| children under 12 years | adult supervision should be given in the use of this product |
| children under 2 years | do not use, consult a physician or dentist |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Boric acid, hydroxypropylcellulose, propylene glycol, purified water, salicylic acid, SD alcohol 38-B, tannic acid Manufactured for: Blairex Laboratories, Inc. P.O. Box 2127 Columbus, IN 47202 USA
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.Use temporarily relieves pain caused by: canker sores minor mouth sores and gum irritations denture and brace pain
Purpose
Information about the drug product’s indications for use.Purpose Oral pain reliever
Spl product data elements
Usually a list of ingredients in a drug product.Zilactin-B benzocaine BORIC ACID HYDROXYPROPYL CELLULOSE (1200000 WAMW) PROPYLENE GLYCOL SALICYLIC ACID ALCOHOL PEPPERMINT OIL TANNIC ACID WATER BENZOCAINE BENZOCAINE
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.PROMOTES HEALING Oral Pain Reliever Zilactin ® -B 6 Hour Canker & Mouth Sore Relief Bioadhesive Promotes Healing Eat and Drink Pain-Free for up to 6 Hours Net wt. 0.25 oz (7g) Principal Display Panel
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Other information do not peel off protective film. Attempting to peel off film may result in skin irritation or tenderness. To remove film, first apply another coat of Zilactin-B Long Lasting Mouth Sore Gel to film, and immediately wipe the area with a moist gauze pad or tissue. contains alcohol 65% by volume store at 15-30°C (59-86°F)
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.Keep out of reach of children . If swallowed, get medical help or contact a poison control center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? Call TOLL FREE 1-800-252-4739 www.zilactin.com Telephone
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a physician if sore mouth symptoms do not improve in 7 days swelling, rash or fever develops irritation, pain or redness persists or worsens apply only to affected area do not exceed recommended dosage avoid contact with the eyes do not use for more than 7 days unless directed by a physician or dentist
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.Warnings Flammable: keep away from fire or flame Allergy Alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics Stop use and ask a physician if sore mouth symptoms do not improve in 7 days swelling, rash or fever develops irritation, pain or redness persists or worsens apply only to affected area do not exceed recommended dosage avoid contact with the eyes do not use for more than 7 days unless directed by a physician or dentist Keep out of reach of children . If swallowed, get medical help or contact a poison control center immediately.
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