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| Product NDC Code | 0363-5334 | ||||
|---|---|---|---|---|---|
| Drug Name | Walgreens mouth sore relief |
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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 | ||||
| Application Number | M022 | ||||
| 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.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.adults and children 2 years of age and over: to assure formation of long0lasting film coating, dry affected area and apply medication undiluted with a cotton swab or fingertip; allow a few seconds for coating to for; use up to 4 times daily, or as directed by a dentist or doctor children under 12 years of age should be supervised in the use of this product children under 2 years of age: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.benzyl alcohol, cetylpyridinium chloride, compound benzoin tincture, dimethyl isosorbide, ethylcellulose, flavor, octylacylamide/acrylates/butylaminoethyl/methylacrylate copolymer, oleth-10, polyethylene glycol, 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.for the temporary relief of pain due to the canker sores, minor irritation of the mouth and gums caused by dentures or othodontic appliances, or minor injury of the mouth or gums
Purpose
Information about the drug product’s indications for use.Oral anesthetic/analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Walgreens Mouth Sore Relief Benzocaine OLETH-10 DIMETHYL ISOSORBIDE POLYETHYLENE GLYCOL 300 BENZOIN, (+/-)- ACRYLATE/BUTYLAMINOETHYL METHACRYLATE/METHYL ACRYLATE/METHYL METHACRYLATE/OCTYLACRYLAMIDE COPOLYMER (40000 WAMW) CETYLPYRIDINIUM CHLORIDE BENZYL ALCOHOL PROPYLENE GLYCOL SUCRALOSE ETHYLCELLULOSE, UNSPECIFIED ALCOHOL RICINUS COMMUNIS SEED BENZOCAINE BENZOCAINE TANNIC ACID Light to dark brown alcohol and mint
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.2824635R1 WLG Mouth Sore Relief
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 more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.
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 cuase methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oygen 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: plae, gray, or blue colored skin (cyanosis) headache rapid heart rate shortness of breath dizziness of lightheadedness fatigue or lack of energy 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
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