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| Product NDC Code | 0363-5335 | ||||
|---|---|---|---|---|---|
| Drug Name | Walgreens severe oral pain reliever |
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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 | LIQUID | ||||
| RxCUI drug identifier | 308657 | ||||
| Application Number | part356 | ||||
| Labeler Name | Walgreens | ||||
| 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 20.0% (w/w)
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 to assure formation of long lasting film coating, dry affected area and apply medication undiluted with applicator. allow a few seconds for coating to form. use up to 4 times daily, or as directed by a dentist or doctor. children 12 years of age should be supervised in the use of this product. children under 2 years of age: ask a dentist or doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Benzyl Alcohol, Cetylpyridinium Chloride, Compound Benzoin Tincture, Dimethyl Isosorbide, Ethylcellulose, Flavor, Octylacrylamideacrylates/butylaminoethyl/methacrylate Copolymer, Oleth-10, PEG-6, Propylene Glycol, Ricinus Communis (Castor) Seed Oil, SD Alcohol 38B, Sucralose, Tannic Acid.
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 for the temporary relief of pain due to canker sores, minor irritation of the mouth and gums caused by dentures or orthodontic appliances, or minor injury of the mouth or gums
Purpose
Information about the drug product’s indications for use.Purpose Oral anesthetic/analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Walgreens Severe Oral Pain Reliever Benzocaine ALCOHOL ETHYLCELLULOSE, UNSPECIFIED TANNIC ACID CETYLPYRIDINIUM CHLORIDE SUCRALOSE BENZYL ALCOHOL PROPYLENE GLYCOL OLETH-10 DIMETHYL ISOSORBIDE RICINUS COMMUNIS SEED WATER POLYETHYLENE GLYCOL, UNSPECIFIED BENZOIN RESIN BENZOCAINE BENZOCAINE Mint Flavor #25797 orange to reddish orange
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.Well at Walgreens PROFESSIONAL STRENGTH Mouth Sore Relief Benzocaine 20% / Oral Anesthetic Liquid 0.5 FL OZ (14.7 mL) blister
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
DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD., DEERFIELD, IL 60015 100% SATISFACTION GUARANTEED walgreens.com MADE IN CANADA
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 right away.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not use for more than 7 days unless told to do so by a dentist or doctor If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or, if swelling, rash or fever develops, see your doctor or dentist promptly. Do not exceed recommended dosage.
Storage and handling
Information about safe storage and handling of the drug product.Other information do not purchase if package has been opened store at 20 - 25 C (68-77F) close cap tightly after use to avoid evaporation avoid contact with eyes avoid contact with clothing and household furniture surfaces to avoid possible staining this is a personal care item, and should be used by one individual only
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 For oral use only 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 When using this product do not use for more than 7 days unless told to do so by a dentist or doctor If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or, if swelling, rash or fever develops, see your doctor or dentist promptly. Do not exceed recommended dosage. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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