Hemorrhoid Anesthetic Ointment

Hemorrhoid Anesthetic Ointment
SPL v3
SPL
SPL Set ID 186c2d32-e8c5-d13d-e063-6294a90a2b0e
Route
TOPICAL
Published
Effective Date 2020-11-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-09

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 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 doctorif 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

benzoic acid, butylated hydroxyanisole, glycerin, lanolin, lanolin alcohol, methylparaben, paraffin, propylparaben, 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 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 doctorif 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

benzoic acid, butylated hydroxyanisole, glycerin, lanolin, lanolin alcohol, methylparaben, paraffin, propylparaben, 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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