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| Product NDC Code | 69571-004 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Family wellness |
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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 | ||||||||
| RxCUI drug identifier | 1293649 | ||||||||
| 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) 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.Adults: Directions -when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gentlydry by patting or blotting with toilet tissue or a soft cloth before application of this product. -apply externally to the affected area up to 4 times daily especially at night r in the morningor after each bowel movement. hildren under 12 years of age: consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.aloe barbadensis leaf extract, Inactive ingredients carboxymethylcellulose sodium, cetyl alcohol, glyceryl monostearate, methylparaben, paraffin, propylene glycol, propylparaben, stearic acid, tween 80, water, xanthan gum
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 anesthetic Protectant
Spl product data elements
Usually a list of ingredients in a drug product.Family Wellness GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, PETROLATUM ALOE VERA LEAF CARBOXYMETHYLCELLULOSE SODIUM CETYL ALCOHOL GLYCERYL MONOSTEARATE PARAFFIN METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER XANTHAN GUM STEARIC ACID POLYSORBATE 80 GLYCERIN GLYCERIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE PRAMOXINE HYDROCHLORIDE PRAMOXINE PETROLATUM PETROLATUM
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 Keep out of reach of children Poison Control Center right away.
Storage and handling
Information about safe storage and handling of the drug product.store at room temperature 68° - 77° F (20° - 25° C) Other information
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 Ask a doctor before use if you have •heart disease •high blood pressure •thyroid disease •diabetes •trouble urinating due to an enlarged prostate gland you are presently taking a prescription Ask a doctor or pharmacist before use if drug for high blood pressure. Stop use and ask a doctor if •bleeding occurs •condition worsens or does not improve within 7 days -if the symptoms being treated do not subside or ir redness, irritation, swelling, pain or other symptoms develop or increase. Some people can develop allergic reactions to ingredients in this product. , ask a health professional before use. If pregnant or breast-feeding do not put this product into the rectum by using fingers or any mechanical device or applicator do not exceed recommended daily dosage unless directed by a doctor
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