ATOPALM Hemorrhoidal Pain Relieving description, usages, side effects, indications, overdosage, supplying and lots more!

ATOPALM Hemorrhoidal Pain Relieving

NeoPharm USA

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
ATOPALM Hemorrhoidal Pain Relieving Cream

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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.

■ 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


Product Labeling




Product Labeling



Product Labeling

ATOPALM Hemorrhoidal Pain Relieving

GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51141-0220
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
GLYCERIN 14.4 g
Phenylephrine Hydrochloride PHENYLEPHRINE 0.25 g
pramoxine hydrochloride PRAMOXINE 1.0 g
petrolatum 15 g

Inactive Ingredients

Ingredient Name Strength
water
CETYL ALCOHOL
POLYSORBATE 60
GLYCERYL MONOSTEARATE
STEARIC ACID
MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA
CHOLESTEROL
Aloe Vera Leaf
METHYLPARABEN
PROPYLPARABEN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 28.3 in 1 TUBE
2 NDC:51141-0220-1 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part346 2012-01-17


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