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| Product NDC Code | 43749-470 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Avedana hemorrhoidal maximum strength |
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| Type | Brand | ||||||||
| Pharm Class | Adrenergic alpha1-Agonists [MoA], Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], alpha-1 Adrenergic Agonist [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | CREAM | ||||||||
| Application Number | part346 | ||||||||
| Labeler Name | Unipack LLC | ||||||||
| 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 Ingredients Glycerin 14.4% Phenylephrine HCL 0.25% Pramoxine HCl 1% White petrolatum 15%
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 Apply externally or in the lower portion of the anal canal only. Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement. -For application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubrcate dispensing cap well, then gently insert dispensing cap partway into the anus.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe barbadensis leaf extract, butylated hydroxytoluene, cetyl esters, cetyl palmitate, glyceryl monostearate, isopropyl myristate, lanolin, methylparaben, mineral oil, polysorbate 60, propylene glycol, propylparaben, sodium citrate, stearic acid, stearyl alcohol, vitamin E, 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 -for temporary relief of pain, soreness, and burning. -helps relieve the local itching and discomfort associated with hemorrhoids. -temporarily shrinks hemorrhoidal tissue. -temporarily provides a coating for relief of anorectal discomforts. -temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful.
Purpose
Information about the drug product’s indications for use.Purpose Protectant Vasoconstrictor Local anasthetic Protectant
Spl product data elements
Usually a list of ingredients in a drug product.Avedana Hemorrhoidal Maximum Strength Hemorrhoidal WATER POLYSORBATE 60 PROPYLENE GLYCOL STEARYL ALCOHOL GLYCERYL MONOSTEARATE MINERAL OIL CETYL PALMITATE ALOE SODIUM CITRATE ISOPROPYL MYRISTATE STEARIC ACID LANOLIN METHYLPARABEN PROPYLPARABEN PETROLATUM PETROLATUM GLYCERIN GLYCERIN PRAMOXINE HYDROCHLORIDE PRAMOXINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE
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.Avedana Hemorrhoidal Cream ® Maximum Strength w/ Aloe & Vitamin E Tube Label Tube Label 0.9oz Tube Label 0.9oz
Avedana Hemorrhoidal Cream ® Maximum Strength w/ Aloe & Vitamin E 1 TUBE | NET WT 0.9 OZ (26 g) 0.9oz Carton Label Carton Label 0.9oz
Avedana Hemorrhoidal Cream ® Maximum Strength w/ Aloe & Vitamin E 1 TUBE | NET WT 1.8 OZ (51 g) 1.8oz Tube Label Tube Label 1.8oz
Avedana Hemorrhoidal Cream ® Maximum Strength w/ Aloe & Vitamin E 1 TUBE | NET WT 1.8 OZ (51 g) 1.8oz Carton Label Carton Label 1.8oz
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have -heart disease -high blood pressure -thyroid disease -diabetes -difficulty in urination due to enlargement of the prostate gland
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.When using this product -do not exceed the recommended daily dosage unless directed by a doctor -do not put into the rectum by using fingers or any mechanical device or applicator
Instructions for use
Information about safe handling and use of the drug product.Directions -adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying cream. When first opening the tube, puncture foil seal with top end of cap. Apply externally or in the lower portion of the anal canal only. Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement. -For application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubrcate dispensing cap well, then gently insert dispensing cap partway into the anus. -thoroughly cleanse dispensing cap after each use and replace cover. -children under 12 years of age: ask a doctor.
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.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if -bleeding occurs -condition worsens or does not improve within 7 days -an allergic reaction develops -the symptom being treated does not subside or if redness, irritation, swelling pain, or other symptoms develop or increase
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at 15ºC - 30ºC (59ºF -86ºF)
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.
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