Hemorrhoid Anesthetic Ointment

Hemorrhoid Anesthetic Ointment
SPL v4
SPL
SPL Set ID 3955ed28-e2b5-1695-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2016-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (0.749 g) Phenylephrine (0.0025 g) Mineral Oil (0.14 g)
Inactive Ingredients
Benzoic Acid Butylated Hydroxyanisole Corn Oil Glycerin Lanolin Lanolin Alcohols Methylparaben Paraffin Propylparaben Shark Liver Oil Thyme Oil .alpha.-tocopherol Acetate Yellow Wax Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-08-05

Description

Active Ingredients Mineral Oil 14% Petrolatum 74.9% Phenylephrine HCL 0.25%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

  • For the temporary relief of local anorectal burning and discomfort associated with hemmorrhoids, anorectal disorders, inflamed hemorrhoidal tissues or piles.
Dosage and Administration

Directions

  • Cleanse the affected area with mild soap and warm water, rinse thoroughly.
  • Dry by patting or blotting with toilet tissue or soft cloth before applying this product.
  • Cover the entire affected area with a thin layer 1 to 3 times daily.
  • Children under 12 years of age need to consult a doctor before using this product.
Description

Active Ingredients Mineral Oil 14% Petrolatum 74.9% Phenylephrine HCL 0.25%

Section 42229-5

Other Information

  • Store at room temperature 20ºC to 25ºC (68ºF to 77ºF)
  • Lot No. & Exp. Date: see crimp of tube.
Section 50565-1

Keep out of reach of children.

If ingested seek medical attention immediately or contact a Poison Control Center right away.

Section 50566-9
  • Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clean-up and occur again within a few days.
  • Do not exceed the recommended daily dosage unless directed by a doctor.

  • In case of bleeding, consult a doctor promptly.

  • Certain persons can develop allergic reactions to ingredients in this product.

  • If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.

  • If you are pregnant, do not use this product without first consulting a doctor.

Section 51727-6

Inactive Ingredients

Purified water, benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohol, methylparaben, mineral oil, paraffin, propylparaben, shark liver oil, thyme oil, tocopherol acetate, yellow wax.

Section 51945-4

PRINCIPAL DISPLAY PANEL

Hemorrhoid Anesthetic Ointment

NET WT 1 OZ (28 g)

Section 55105-1

Purpose

Protectant

Protectant

Vasoconstrictor

Section 55106-9

Active Ingredients

Mineral Oil 14%

Petrolatum 74.9%

Phenylephrine HCL 0.25%


Structured Label Content

Indications and Usage (34067-9)

Uses

  • For the temporary relief of local anorectal burning and discomfort associated with hemmorrhoids, anorectal disorders, inflamed hemorrhoidal tissues or piles.
Dosage and Administration (34068-7)

Directions

  • Cleanse the affected area with mild soap and warm water, rinse thoroughly.
  • Dry by patting or blotting with toilet tissue or soft cloth before applying this product.
  • Cover the entire affected area with a thin layer 1 to 3 times daily.
  • Children under 12 years of age need to consult a doctor before using this product.
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 42229-5 (42229-5)

Other Information

  • Store at room temperature 20ºC to 25ºC (68ºF to 77ºF)
  • Lot No. & Exp. Date: see crimp of tube.
Section 50565-1 (50565-1)

Keep out of reach of children.

If ingested seek medical attention immediately or contact a Poison Control Center right away.

Section 50566-9 (50566-9)
  • Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clean-up and occur again within a few days.
  • Do not exceed the recommended daily dosage unless directed by a doctor.

  • In case of bleeding, consult a doctor promptly.

  • Certain persons can develop allergic reactions to ingredients in this product.

  • If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.

  • If you are pregnant, do not use this product without first consulting a doctor.

Section 51727-6 (51727-6)

Inactive Ingredients

Purified water, benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohol, methylparaben, mineral oil, paraffin, propylparaben, shark liver oil, thyme oil, tocopherol acetate, yellow wax.

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL

Hemorrhoid Anesthetic Ointment

NET WT 1 OZ (28 g)

Section 55105-1 (55105-1)

Purpose

Protectant

Protectant

Vasoconstrictor

Section 55106-9 (55106-9)

Active Ingredients

Mineral Oil 14%

Petrolatum 74.9%

Phenylephrine HCL 0.25%


Advanced Ingredient Data


Raw Label Data

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