HEMORRHOIDAL-OINTMENT- lidocaine 4.00, phenylephrine hydrochloride 0.25 ointment

Hemorrhoidal-Ointment by

Drug Labeling and Warnings

Hemorrhoidal-Ointment by is a Otc medication manufactured, distributed, or labeled by Rrhoid Rage. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine 4%..................................................Local Anesthetic

Phenylephrine Hydrochloride 0.25%...............Vasoconstrictor

PURPOSE

Local anesthetic, Vasoconstrictor

INDICATIONS & USAGE

-Helps relieve the pain, itching, and burning associated with hemorrhoids.

-Temporarily reduces the swelling associated with irritated hemorrhoidal
tissue and other anorectal disorders.
-Temporarily provides a coating for relief of anorectal discomforts.
-Temporarily protects irritated areas and inflamed perianal skin.

WARNINGS

For external 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
-Avoid contact with eyes.
-Do not exceed 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 use and ask a doctor if
-Bleeding occurs.
-Condition worsens or does not improve within 7 days.
-Allergic reaction occurs to ingredients in this product.
-Symptom being treated does not subside or if redness, irritation, swelling,
pain or other symptoms develop or increase.

If pregnant or breastfeeding, ask a doctor before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a
Poison Control Center right away.

DOSAGE & ADMINISTRATION

-When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.
Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
-Adults and children 12 years and older: apply externally to the affected area up to 4 times daily.
-Children under 12 years of age: consult a doctor.

Other information
-Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F).

INACTIVE INGREDIENT

aloe extract AQ, balsam fir, butylated hydroxyanisol, glycerin, lanolin alcohols, lanolin USP,
magnesium sulfate, methyl paraben, mineral oil, petrolatum, propylparaben, witch hazel, white
bees wax.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEMORRHOIDAL-OINTMENT 
lidocaine 4.00, phenylephrine hydrochloride 0.25 ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82433-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	0.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BALSAM FIR LEAFY TWIG (UNII: H1TFV1454Z)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
LANOLIN (UNII: 7EV65EAW6H)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
ALOE (UNII: V5VD430YW9)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
GLYCERIN (UNII: PDC6A3C0OX)
WITCH HAZEL (UNII: 101I4J0U34)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82433-101-01	1 in 1 CARTON	06/06/2022
1		28 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 final	part346	06/06/2022

Labeler - Rrhoid Rage (035330878)

Registrant - Rrhoid Rage (035330878)