Family Wellness Hemorrhoid Ointment 2oz 91319

Family Wellness Hemorrhoid Ointment 2oz 91319
SPL v5
SPL
SPL Set ID fe3293bc-80b5-b60a-e053-6394a90a4ede
Route
TOPICAL
Published
Effective Date 2023-09-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-18

Description

Drug Facts Active ingredients Purposes Mineral oil 14.0%.....................................................................Skin protectant Petrolatum 74.9%....................................................................Skin protectant Phenylephrine HCI 0.25%........................................................Vasoconstrictor


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
  • FOR INTRARECTAL USE: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into rectum. Thoroughly clean applicator after each use and replace cover. Also apply ointment to external area.
  • regular use provides continue therapy for relief of symptoms
  • children under 12 years of age: ask a doctor
Dosage and Administration

Distributed by: Midwood Brands, LLC

500 Volvo Pkwy, Chesapeake, VA 23320 USA

Made in China

Description

Drug Facts Active ingredients Purposes Mineral oil 14.0%.....................................................................Skin protectant Petrolatum 74.9%....................................................................Skin protectant Phenylephrine HCI 0.25%........................................................Vasoconstrictor

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 the rectum causes additional 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 of pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

Section 50570-1

Do not use this product if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • difficulty in urination due to enlargement of the prostate gland
  • diabetes
Section 51727-6

Inactive ingredients alcohol, alpha tocopherol acetate, glycerin, lanolin, methylparaben, polysorbate 80, propylparaben, purified water, stearyl alcohol, thyme oil, 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

Drug Facts

Active ingredients Purposes

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

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

Phenylephrine HCI 0.25%........................................................Vasoconstrictor


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
  • FOR INTRARECTAL USE: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into rectum. Thoroughly clean applicator after each use and replace cover. Also apply ointment to external area.
  • regular use provides continue therapy for relief of symptoms
  • children under 12 years of age: ask a doctor
Dosage and Administration (34068-7)

Distributed by: Midwood Brands, LLC

500 Volvo Pkwy, Chesapeake, VA 23320 USA

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 the rectum causes additional 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 of pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

Section 50570-1 (50570-1)

Do not use this product if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • difficulty in urination due to enlargement of the prostate gland
  • diabetes
Section 51727-6 (51727-6)

Inactive ingredients alcohol, alpha tocopherol acetate, glycerin, lanolin, methylparaben, polysorbate 80, propylparaben, purified water, stearyl alcohol, thyme oil, 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)

Drug Facts

Active ingredients Purposes

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

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

Phenylephrine HCI 0.25%........................................................Vasoconstrictor


Advanced Ingredient Data


Raw Label Data

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