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| Product NDC Code | 79481-0118 | ||||
|---|---|---|---|---|---|
| Drug Name | Oral anesthetic liquid |
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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 | M022 | ||||
| Labeler Name | Meijer, 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 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 Adults and children 2 years of age and older: wipe liquid on with cotton, or cotton swab, or fingertip, apply to the affected area up to 4 times daily or as directed by a doctor/dentist children under 12 years of age: adult supervision should be given in the use of this product children under 2 years of age: do not use for denture irritation apply a thin layer to the affected area; do not reinsert dental work until irritation/pain is relieved; rinse mouth well after reinserting
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Benzyl Alcohol, D&C Yellow no. 10, FD&C Blue no. 1, FD&C Red no. 40, Flavor, Methylparaben, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water
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.Uses Temporarily relieves pain associated with the following mouth and gum irritations: toothache sore gums canker sores braces minor dental procedures dentures
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.Oral Anesthetic Liquid Benzocaine BENZYL ALCOHOL BENZOCAINE BENZOCAINE WATER POLYETHYLENE GLYCOL 400 D&C YELLOW NO. 10 FD&C BLUE NO. 1 SACCHARIN SODIUM SACCHARIN PROPYLENE GLYCOL METHYLPARABEN FD&C RED NO. 40 dark orange/red to brown
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.Card R1
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
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 Keep out of reach of children. If 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.Warnings METHEMOGLOBINEMIA WARNING: Use of this product may cause methemoglobinemia, a rare but serious confition 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, gray, or blue colored skin (cyanosis) headache rapid heart rate shortness of breath dizziness or 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 Do not use for teething in children under 2 years of age When using this product avoid contact with eyes do not exceed recommended dosage do not use for more than 7 days unless directed by a dentist or doctor Stop use and ask doctor if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops
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