Active Ingredients
Mineral Oil 14%
Petrolatum 71.9%
Phenylephrine HCl 0.25%
Atopalm Hemorrhoidal
FDA Label NDC 51141-0230
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Neopharm Usa for the product Atopalm Hemorrhoidal (NDC 51141-0230). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, ask a doctor before using if you have, ask a doctor of pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Protectant
Protectant
Vascocontrictor
Uses
■ for temporary relief of 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 protects the inflamed, irritated anorectal surface to help make bowel movements less painful.
Warnings
For external and/or intrarectal use only.
Ask A Doctor Before Using If You Have
■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to an enlarged prostate gland
Ask A Doctor Of Pharmacist Before Use If You Are
■ presently taking a prescription drug for high blood pressure or depression.
When Using This Product
■ do not exceed the recommended daily dosage unless directed by a doctor
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.
If Pregnant Or Breast Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help immediately or contact a Poison Control Center right away.
Directions
Do not use if foil seal under cap is broken or missing. ■ 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 ointment ■ when first opening the tube, puncture foil seal with top end of cap ■ apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement ■ for intrarectal use, remove cover from the applicator, attach applicator to tube, lubricate applicator well, then gently insert applicator into the rectum ■ thoroughly cleanse applicator after each use and replace cover ■ also apply ointment to external area ■ regular use provides continual therapy for relief ofsymptoms ■ children under 12 years of age, ask a doctor.
Storage And Handling
store at 20° – 25°C (68° – 77°F)
Inactive Ingredients
COD LIVER OIL, GLYCERIN, LANOLIN, BEES WAX, SQUALANE, CHOLESTEROL, MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA, STEARIC ACID, BUTYLATED HYDROXYTOLUENE, METHYLPARABEN, PARAFFIN, PROPYLPARABEN, PURIFIED WATER, SODIUM BENZOATE, THYMUS VULGARIS (THYME) FLOWER/LEAF OIL, TOCOPHERYL ACETATE.
Questions Or Information Call Toll Free
1-855- ATOPALM
Atopalm Hemorrhoidal Ointment 2Oz (51141-0230-2)
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