signature care hemorrhoidal ointment 1 oz (with applicator) 78982 zdp

signature care hemorrhoidal ointment 1 oz (with applicator) 78982 zdp
SPL v7
SPL
SPL Set ID 3c8b43f3-6e1e-499e-ba71-ffdf836f6743
Route
topical
Published
Effective Date 2016-01-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
petrolatum (749 mg) phenylephrine (2.5 mg) mineral oil (140 mg)
Inactive Ingredients
glycerin lanolin methylparaben polysorbate 80 propylparaben stearyl alcohol thyme oil alcohol .alpha.-tocopherol acetate water white wax

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2016-01-20
Description

Active ingredients                                               Purpose Mineral oil 14%..............................................Protectant Petrolatum 74.9%..........................................Protectant Phenylephrine HCI 0.25%..........................Vasconstrictor

Medication Information

Warnings and Precautions

Warnings

For external and/or intrarectal use only

Active Ingredient

Active ingredients                                               Purpose

Mineral oil 14%..............................................Protectant

Petrolatum 74.9%..........................................Protectant

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

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, 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  
  • interacetal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into thoroughly cleanse applicator after each use and replace cover
  • also apply ointment to external area
  • regular use provides continual therapy for relief of symptoms
  • children under 12 years of age: ask a doctor
Dosage and Administration

Distributed by:

Better Living Brands LLC

P.O. Box 99

Pleasanton, CA 94566-0009

1-888-723-3929

www.betterlivingbrandsLLC.com

Made in China

Description

Active ingredients                                               Purpose Mineral oil 14%..............................................Protectant Petrolatum 74.9%..........................................Protectant Phenylephrine HCI 0.25%..........................Vasconstrictor

Section 44425-7

Other information

  • store at 20-25°C (68-77°F)
  • Lot No. & Exp. Date: see box or see crimp of tube
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control right away.

Section 50566-9

Stop use and ask a doctor if

  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • introduction of applicator into 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 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 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, methylparaben, 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 bowel movements less painful

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external and/or intrarectal use only

Active Ingredient (55106-9)

Active ingredients                                               Purpose

Mineral oil 14%..............................................Protectant

Petrolatum 74.9%..........................................Protectant

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

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, 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  
  • interacetal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into thoroughly cleanse applicator after each use and replace cover
  • also apply ointment to external area
  • regular use provides continual therapy for relief of symptoms
  • children under 12 years of age: ask a doctor
Dosage and Administration (34068-7)

Distributed by:

Better Living Brands LLC

P.O. Box 99

Pleasanton, CA 94566-0009

1-888-723-3929

www.betterlivingbrandsLLC.com

Made in China

Section 44425-7 (44425-7)

Other information

  • store at 20-25°C (68-77°F)
  • Lot No. & Exp. Date: see box or see crimp of tube
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • introduction of applicator into 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 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 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, methylparaben, 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 bowel movements less painful

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:32.178338 · Updated: 2026-03-14T23:12:47.494493