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| Product NDC Code | 83838-153 | ||||
|---|---|---|---|---|---|
| Drug Name | Bloop fissure healing anorectal topical |
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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 | M015 | ||||
| Labeler Name | Three Nations Corp | ||||
| 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.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.Gently dry by patting or blotting with toilet tissue or soft cloth before applying Carefully apply medication to the perianal skin and anal canal with a clean finger 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Benzyl alcohol, carbomer, cholesterol, euterpe oleracea fruit oil, hydrogenated lecithin, isopropyl myristate, pentaclethra macroloba seed oil, polysorbate 80, propanediol, tocopheryl acetate, triethanolamine, 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.Helps relieve the pain, itching, and burning associated with hemorrhoids, fissures, and other anorectal disorders
Purpose
Information about the drug product’s indications for use.Anorectal (hemorrhoidal)
Spl product data elements
Usually a list of ingredients in a drug product.Bloop Fissure Healing Anorectal Topical Lidocaine CARBOMER 940 BENZYL ALCOHOL CHOLESTEROL ACAI OIL LIDOCAINE LIDOCAINE EDETATE DISODIUM HYDROGENATED SOYBEAN LECITHIN PROPANEDIOL ISOPROPYL MYRISTATE PENTACLETHRA MACROLOBA SEED OIL POLYSORBATE 80 .ALPHA.-TOCOPHEROL ACETATE WATER TROLAMINE
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.Carton
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.If swallowed, get medical help or contact a Poison Control Center immediately.
Pregnancy or breast feeding
Pregnancy or Breast feedingAsk a health professional before use.
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.For external use only (skin of the perianal area and anal canal). When using this product do not exceed recommended dosage unless directed by a doctor do not put this product into the 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 rectal bleeding occurs 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
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