Atopalm Hemorrhoidal Pain Relieving
FDA Label NDC 51141-0220

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 Pain Relieving (NDC 51141-0220). 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 ingredient, 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

→ Active Ingredient

→ 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

→ If Pregnant Or Breast Feeding,

→ Keep Out Of Reach Of Children.

→ Directions

→ Storage And Handling

→ Inactive Ingredients

→ Questions Or Information Call Toll Free

→ Product Labeling

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.