ATOPALM HEMORRHOIDAL- mineral oil, petrolatum, phenylephrine hydrochloride ointment

ATOPALM Hemorrhoidal by

Drug Labeling and Warnings

ATOPALM Hemorrhoidal by is a Otc medication manufactured, distributed, or labeled by NeoPharm USA, NeoPharm Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 of
symptoms
■ 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)

Outer Package

Inner Package

INGREDIENTS AND APPEARANCE

ATOPALM HEMORRHOIDAL 
mineral oil, petrolatum, phenylephrine hydrochloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51141-0230
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	14 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	71.9 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	0.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
COD LIVER OIL (UNII: BBL281NWFG)
GLYCERIN (UNII: PDC6A3C0OX)
LANOLIN (UNII: 7EV65EAW6H)
SQUALANE (UNII: GW89575KF9)
CHOLESTEROL (UNII: 97C5T2UQ7J)
MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)
STEARIC ACID (UNII: 4ELV7Z65AP)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PARAFFIN (UNII: I9O0E3H2ZE)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
THYME OIL (UNII: 2UK410MY6B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51141-0230-2	1 in 1 CARTON
1		56 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	07/18/2012

Labeler - NeoPharm USA (965502912)

Establishment
Name	Address	ID/FEI	Business Operations
NeoPharm Co., Ltd.		631101883	manufacture(51141-0230)