FDA Label for Atopalm Hemorrhoidal Pain Relieving

View Indications, Usage & Precautions

Atopalm Hemorrhoidal Pain Relieving 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 Ingredient



Glycerin 14.4%
Phenylephrine HCl 0.25%
Pramoxine HCl 1%
White Petrolatum 15%


Purpose



Protectant
Vasoconstrictor
Local Anesthetic
Protectant


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.


Warnings



For external 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 ■ do not put into the rectum by using fingers or an mechanical device or applicator.


Stop Use And Ask A Doctor If



■ bleeding occurs ■ condition worsens or does not improve within 7 days ■ an allergic reaction develops ■ the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.


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 cream ■ when first opening the tube, puncture foil seal with top end of cap ■ apply externally or in the lower portion of the anal canal only ■ apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement ■ for application in the lower anal canal, remove cover from the dispensing cap. Attach dispensing cap to tube, Lubricate dispensing
cap well, then gently insert dispensing cap partway into the anus. ■ thoroughly cleanse dispensing cap after each use and replace cover.

Children under 12 years of age
■ ask a doctor.


Storage And Handling



■ store at 68° – 77°F (20° – 25°C)


Inactive Ingredients



WATER, CETYL ALCOHOL, POLYSORBATE 60, GLYCERYL STEARATE, STEARIC ACID, MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA, CHOLESTEROL, ALOE VERA GEL, METHYLPARABEN, PROPYLPARABEN.


Questions Or Information Call Toll Free



1-855- ATOPALM


Product Labeling



Rapid Soothing Pain Relief

US Patented Technology

ATOPALM
HEMORRHOIDAL PAIN RELIEVING CREAM
With US Patented MLE Technology

Rapid Relief from Painful Burning, Itching, External Discomfort, Shrinks Swollen Hemorrhoidal Tissue

Soothing cream with pain relieving ingredient. Temporarily Protects Irritated Tissue, Rapid Relief from External Discomfort

Strong Pain Relief – Soothes Irritated Hemorrhoidal Tissue

Net Wt. 1 oz /28.3 g

US Patent # US 6221371B1
Distributed by: NeoPharm USA, 1 Oyster Bay Drive, Rumson, NJ 07760
Made in Korea








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