DRS PHARMACY HEMORRHOIDAL- phenylephrine hcl ointment

Drs pharmacy HEMORRHOIDAL by

Drug Labeling and Warnings

Drs pharmacy HEMORRHOIDAL by is a Otc medication manufactured, distributed, or labeled by OL PHARMA TECH, LLC Drs PHARMACY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

1. Phenylephrine HCI, 0.25%
2. Petrolatum 74.9 %
3. mineral oil 14 %

PURPOSE

• Vasoconstrictor
• protectant

USES

• helps relieve the local itching and discomfort associated with hemorrhoids
• temporarily shrinks hemorrhoidal tissue and relieves burning
• temporarily provides a coating for relief of anorectal discomforts
• aids in protecting irritated anorectal areas
• temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

WARNINGS

For external use only and / or intrarectal use only

ASK A DOCTOR BEFORE USE IF YOU HAVE

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficulty in urination due to enlargement of the prostate gland

Ask a doctor or 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 this product into the rectum by using fingers or any mechanical device or applicator

STOP USING AND ASK YOUR DOCTOR IF

• bleeding occurs
• condition worsens or does not improve within 7 days

IF PREGNENT 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 wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying gel.
• 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
• children under 12 years of age: ask a doctor

OTHER INFORMATION

store at 20-25°C (68-77°F)

INACTIVE INGREDIENTS

methylparaben, propylparaben, purified water, benzoic acid, butylated hydroxyanisole, corn oil, glycerine, lanolin, lanolin alcohols, mineral oil, paraffin, tocopherol, white wax

QUESTIONS

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DRS PHARMACY HEMORRHOIDAL 
phenylephrine hcl ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80489-956
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	749 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 1 g
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	140 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
PARAFFIN (UNII: I9O0E3H2ZE)
CORN OIL (UNII: 8470G57WFM)
GLYCERIN (UNII: PDC6A3C0OX)
THYME (UNII: CW657OBU4N)
WHITE WAX (UNII: 7G1J5DA97F)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
WATER (UNII: 059QF0KO0R)
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80489-956-01	1 in 1 CARTON	11/01/2021
1		28.3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	11/01/2021

Labeler - OL PHARMA TECH, LLC Drs PHARMACY (021170377)

Registrant - OL PHARMA TECH, LLC Drs PHARMACY (021170377)

Establishment
Name	Address	ID/FEI	Business Operations
OL PHARMA TECH, LLC Drs PHARMACY		021170377	manufacture(80489-956)