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| Product NDC Code | 69571-006 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Family wellness |
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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 | M015 | ||||||
| Labeler Name | FRONT PHARMACEUTICAL PLC | ||||||
| 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 (in each gram) Mineral oil 14% Petrolatum 74.9% Phenylephrine HCl 0.25%
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 each bowel movement. For intrarectal use: •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.beeswax, benzoic acid, cetyl alcohol, glycerin, laureth-23, Inactive ingredients methylparaben, 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.•helps relieve the local itching and discomfort associated with hemorrhoids. Uses •Temporarily shrinks hemorrhoid tissue and relieves burning. •Temporarily provides a coating for relief of anorectal burning. •Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
Purpose
Information about the drug product’s indications for use.Purposes Protectant Protectant Vasoconstrictor
Spl product data elements
Usually a list of ingredients in a drug product.Family wellness Mineral oil, Petrolatum, Phenylephrine HCl YELLOW WAX BENZOIC ACID CETYL ALCOHOL GLYCERIN LAURETH-23 METHYLPARABEN PROPYLPARABEN STEARYL ALCOHOL MINERAL OIL MINERAL OIL PETROLATUM PETROLATUM 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.image description
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 right Keep out of reach of children. away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.store at room temperature 68° - 77° F (20°-25° C). Other information
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.1-800-639-3803 Weekdays 9 AM to 4 PM EST Questions?
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 intrarectal use only Ask a doctor before use if you have •heart disease •high blood pressure •thyroid disease •diabetes •trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure. Stop use and ask a doctor if •bleeding occurs •condition worsens or does not improve within 7 days. •introduction of the applicator into the rectum causes additional pain. , ask a health professional before use. If pregnant or breast-feeding
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