Gnp Hemorrhoidal Ointment 2oz (with Applicator) 43376 Zdp

Gnp Hemorrhoidal Ointment 2oz (with Applicator) 43376 Zdp
SPL v6
SPL
SPL Set ID b0f0ef97-9add-717f-e053-2a95a90a0eb0
Route
TOPICAL
Published
Effective Date 2021-01-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (2.5 mg) Petrolatum (749 mg) Mineral Oil (140 mg)
Inactive Ingredients
Thyme Oil Water White Wax .alpha.-tocopherol Acetate Glycerin Polysorbate 80 Propylparaben Alcohol Lanolin Methylparaben Stearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-26

Description

Active ingredients Purposes Mineral oil 14.0%.....................................................Skin protectant Petrolatum 74.9%....................................................Skin protectant Phenylephrine HCI 0.25%.......................................Vasconstrictor


Medication Information

Warnings and Precautions

Warnings

For external and/or intrarectal use only

Indications and Usage

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, peel back foil seal
  • 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, lubricant applicator well and gently insert applicator into the rectum
  • thoroughly cleanse applicator after each use and replace cover
  • also apply ointment to external area
  • regular use provided continual therapy for relief of symptoms
  • children under 12 years of age: ask a doctor
Dosage and Administration

Distributed By:

Amerisource Bergen

Made in China

Description

Active ingredients Purposes Mineral oil 14.0%.....................................................Skin protectant Petrolatum 74.9%....................................................Skin protectant Phenylephrine HCI 0.25%.......................................Vasconstrictor

Section 44425-7

Other information

  • store at room temperature 20-25°C (68-77°F)
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

Stop use and ask a doctor if

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • introduction of applicator into rectum causes addition pain
Section 50567-7

When using this product

  • do not exceed the recommended daily dosage unless directed by a doctor
Section 50569-3

Ask a doctor before use if you have

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

Ask a doctor of pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression

Section 51727-6

Inactive ingredients

.alpha.-tocopherol acetate, alcohol, glycerin, lanolin, methyparaben, polysorbate 80, propylparaben, stearyl alcohol, thyme oil, purified water, white wax

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

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
Section 55106-9

Active ingredients Purposes

Mineral oil 14.0%.....................................................Skin protectant

Petrolatum 74.9%....................................................Skin protectant

Phenylephrine HCI 0.25%.......................................Vasconstrictor


Structured Label Content

Indications and Usage (34067-9)

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, peel back foil seal
  • 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, lubricant applicator well and gently insert applicator into the rectum
  • thoroughly cleanse applicator after each use and replace cover
  • also apply ointment to external area
  • regular use provided continual therapy for relief of symptoms
  • children under 12 years of age: ask a doctor
Dosage and Administration (34068-7)

Distributed By:

Amerisource Bergen

Made in China

Warnings and Precautions (34071-1)

Warnings

For external and/or intrarectal use only

Section 44425-7 (44425-7)

Other information

  • store at room temperature 20-25°C (68-77°F)
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • introduction of applicator into rectum causes addition pain
Section 50567-7 (50567-7)

When using this product

  • do not exceed the recommended daily dosage unless directed by a doctor
Section 50569-3 (50569-3)

Ask a doctor before use if you have

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

Ask a doctor of pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression

Section 51727-6 (51727-6)

Inactive ingredients

.alpha.-tocopherol acetate, alcohol, glycerin, lanolin, methyparaben, polysorbate 80, propylparaben, stearyl alcohol, thyme oil, purified water, white wax

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

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
Section 55106-9 (55106-9)

Active ingredients Purposes

Mineral oil 14.0%.....................................................Skin protectant

Petrolatum 74.9%....................................................Skin protectant

Phenylephrine HCI 0.25%.......................................Vasconstrictor


Advanced Ingredient Data


Raw Label Data

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