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  5. Label Information: Atopalm Hemorrhoidal

FDA Label for Atopalm Hemorrhoidal

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USING IF YOU HAVE
    6. ASK A DOCTOR OF PHARMACIST BEFORE USE IF YOU ARE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. STORAGE AND HANDLING
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR INFORMATION CALL TOLL FREE
    15. ATOPALM HEMORRHOIDAL OINTMENT 2OZ (51141-0230-2)

Atopalm Hemorrhoidal Product Label

The following document was submitted to the FDA by the labeler of this product Neopharm Usa. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients



Mineral Oil 14%

Petrolatum 71.9%

Phenylephrine HCl 0.25%


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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