HEMORRHOIDAL- mineral oil, petrolatum, phenylephrine ointment

Hemorrhoidal by

Drug Labeling and Warnings

Hemorrhoidal by is a Otc medication manufactured, distributed, or labeled by Geritrex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient                    PurposeMineral Oil - 14%                   ProtectantPetrolatum - 71.9%              ProtectantPhenylephrine - 0.25%          Astringent

PURPOSE

Uses:

• Helps relieve local itching and discomfort with hemorrhoids.
• Temporarily shrinks hemorrhoid tissues and relieves burning.
• Temporarily provides a coating for relief of anorectal discomforts
• Temporarily protects the inflamed, irritated anorectal surface to hlep make bowel movements less painful

Warnings:

For external and/or intrarectal use only

ASK DOCTOR

Ask a doctor before use if you have

• Heart disease
• Thyroid disease
• Diabetes
• High Blood pressure
• Difficulty in urination due to enlargement of the prostate gland

ASK DOCTOR/PHARMACIST

Ask a doctor or a 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 or contact a poison control center right away.

Directions:

• Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing tissue.
• Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this ointment
• Apply to affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.

For Intrarectal use

• Remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert into the rectum.
• Thoroughly cleanse applicator after each use
• Also apply ointment to external area
• Regular use provides continual therapy for relief of symptoms
• Children under 12 years of age, consult a doctor

Other Information:

Store at room temperature but not over 80­° F
Lot No. & Exp Date: See tube

Inactive Ingredients:

Beeswax, benzoic acid, BHA, corn oil, glycern, lanolin alcohol, methyparaben, paraffin, propylparaben, shark liver oil, thyme, tocopherol, water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEMORRHOIDAL 
mineral oil, petrolatum, phenylephrine ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54162-044
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	7.98 g  in 57 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	40.983 g  in 57 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	0.1425 g  in 57 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
BENZOIC ACID (UNII: 8SKN0B0MIM)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
CORN OIL (UNII: 8470G57WFM)
GLYCERIN (UNII: PDC6A3C0OX)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
METHYLPARABEN (UNII: A2I8C7HI9T)
PARAFFIN (UNII: I9O0E3H2ZE)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SHARK LIVER OIL (UNII: 4B24275HEU)
THYME (UNII: CW657OBU4N)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54162-044-02	57 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	07/31/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	07/31/2015

Labeler - Geritrex LLC (112796248)

Establishment
Name	Address	ID/FEI	Business Operations
Geritrex LLC		112796248	manufacture(54162-044)