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| Product NDC Code | 69396-020 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Hemorrhoidalointment |
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| Type | Brand | ||||||
| Pharm Class | Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | OINTMENT | ||||||
| RxCUI drug identifier | 1372298 | ||||||
| Application Number | part346 | ||||||
| Labeler Name | Trifecta Pharmaceuticals USA 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 Ingredient Phenylephrine HCI 0.25%
Active Ingredient Mineral Oil 14%
Active Ingredient Petrolatum 74.9%
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 12 years of age and older for topical use: Clean the affected area and pat or dab dry before applying ointment Apply to the affected area up to 4 times daily, especially after bowel movement Attach included applicator to tube Lubricate applicator tip and gently insert into rectum Thoroughly clean applicator after each use and replace cover Children under 12 years of age: ask a doctor before use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Beeswax, Benzoic Acid, Cetyl alcohol, Glycerol Methylparaben, Polyoxyethylene lauryl ether, Propylparaben, Stearyl alcohol
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 Helps relieve the local itching and discomfort associated with hemorrhoids Temporarily shrinks hemorrhoidal tissue and relieves burning Temporarily provides a coating for relief of anorectal discomforts Temporarily profects the inflamed, irritated anorectal surface to help make bowel movements less painful
Purpose
Information about the drug product’s indications for use.Purpose Vasoconstrictor
Purpose Protectant
Purpose Protectant
Spl product data elements
Usually a list of ingredients in a drug product.HemorrhoidalOintment Mineral Oil, Petrolatum, Phenylephrine HCI MINERAL OIL MINERAL OIL PETROLATUM PETROLATUM PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE PROPYLPARABEN METHYLPARABEN WHITE WAX THYME OIL LANOLIN GLYCERIN PARAFFIN
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.4042 HEMORRHOIDAL OINTMENT 2OZ UPC REV14 050923 CDER
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
Distributed By: Trifecta Pharamceuticals USA, LLC.® 101 NE Third Ave. Suite 1500 Ft. Lauderdale, FL. 33301 USA www.trifecta-pharma.com
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 Doctor if Bleeding occurs Condition worsens or does not improve within 7 days Introduction of applicator into the rectum causes additional pain
Pregnancy or breast feeding
Pregnancy or Breast feedingIf Pregnant or Breast-Feeding Ask a doctor before use
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store at room temperature 20°-25°C (68°-77°F) Close cap tightly after use Questions? Call 1-888-296-9067
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 and/or anorectal use only Ask doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland Ask doctor before use if you are presently taking a prescription drug for high blood pressure
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