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Product NDC Code | 83462-001 | ||||
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Drug Name | Beaueli |
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Type | Brand | ||||
Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
RxCUI drug identifier | 1366789 | ||||
Application Number | part348 | ||||
Labeler Name | EUbizrival LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Lidocaine 5%
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 When practical clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or bloating with toilet tissue or soft cloth before applying. Adults and children 12 years and older: apply externally to the affected area up to 6 times a day. Children under 12 years of age: consult a doctor To use finger cots: roll one finger cot over finger. Gently squeeze cream on to finger cot. Smooth a layer of the cream.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.water, glycerine, Lidocaine Lsopropyl palmitate, Aloe barbadensis leaf juice, Retinol,Helianthus annuus (sunflower)seed oil, Glyceryl stearate, Pentylene glycol, Butyrospermum parkii (shea)butter,Cetyl alcohol, Piper methysticum leaf/root/stem extract, Peg-100 stearate, Tocopheryl acetate.
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 For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders.
Purpose
Information about the drug product’s indications for use.Purpose Local Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.BEAUELI Lidocaine WATER GLYCERIN ALOE SHEA BUTTER RETINOL SUNFLOWER OIL GLYCERYL STEARATE SE PENTYLENE GLYCOL CETYL ALCOHOL PIPER METHYSTICUM WHOLE PEG-100 STEARATE .ALPHA.-TOCOPHEROL ACETATE, D- LIDOCAINE LIDOCAINE
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.Product label image description
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.Other information Store at room temperature. Avoid direct sunlight. Do not use if temper evident packaging has been breached or is missing.
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 external use only When using this product Do not get into eyes. Do not exceed recommend dosage unless directed by doctor. Do not put this product into rectum by using fingers or any mechanical device or applicator. Stop use and ask a doctor if condition worsens or does not improve within 7 days. allergic reaction occurs to ingredients in this product. symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase. symptoms clear up and return within a few days. Keep out of reach of children. If swallowed, get medical help. Do not use if allergic to any ingredients. If pregnant or breastfeeding ask a health professional before use.
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