MINERAL OIL, PETROLATUM AND PHENYLEPHRINE HCL- mineral oil, petrolatum, phenylephrine hcl ointment

Mineral Oil, Petrolatum and Phenylephrine HCl by

Drug Labeling and Warnings

Mineral Oil, Petrolatum and Phenylephrine HCl by is a Otc medication manufactured, distributed, or labeled by Axcentria Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENTS

Mineral oil 14%

Petrolatum 71.9%

Phenylephrine HCl 0.25%

PURPOSES

Protectant

Protectant

Vasoconstrictor

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
• 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 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.

Stop use and ask a doctor if

• bleeding occurs
• condition worsens or does not improve within 7 days
• introduction of 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 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 to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
• intrarectal use:
  • remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum
  • thoroughly cleanse applicator after each use and replace cover
• also apply ointment to external area
• children under 12 years of age: ask a doctor

OTHER INFORMATION

store at 20-25°C (68-77°F)

INACTIVE INGREDIENTS

benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, shark liver oil, thymus vulgaris (thyme) flower/leaf oil, tocopherols excipient, white wax

QUESTIONS?

To report adverse drug event call: (800) 616-2417

PRINCIPAL DISPLAY PANEL - 56.8 g Tube Carton

HEMORRHOIDAL
OINTMENT

TAMPER-EVIDENT: Do not use if printed "safety sealed" overwrap is broken or missing.

• Prompt, Soothing Relief from painful burning, itching and discomfort
• Shrinks swollen hemorrhoidal tissue
• Protects irritated tissue
• Relieves internal and external discomfort

NET WT 2 OZ (56.8 g)

INGREDIENTS AND APPEARANCE

MINERAL OIL, PETROLATUM AND PHENYLEPHRINE HCL 
mineral oil, petrolatum, phenylephrine hcl ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49743-3047
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	140 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	741 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
CORN OIL (UNII: 8470G57WFM)
GLYCERIN (UNII: PDC6A3C0OX)
LANOLIN (UNII: 7EV65EAW6H)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
METHYLPARABEN (UNII: A2I8C7HI9T)
PARAFFIN (UNII: I9O0E3H2ZE)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SHARK LIVER OIL (UNII: 4B24275HEU)
THYME (UNII: CW657OBU4N)
TOCOPHEROL (UNII: R0ZB2556P8)
WHITE WAX (UNII: 7G1J5DA97F)

Product Characteristics
Color	YELLOW (smooth yellow ointment)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49743-3047-1	1 in 1 CARTON
1		56.8 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part346	06/28/2013

Labeler - Axcentria Pharmaceuticals, LLC (961871501)

Establishment
Name	Address	ID/FEI	Business Operations
Axcentria Pharmaceuticals, LLC		961871501	ANALYSIS(49743-3047) , MANUFACTURE(49743-3047)