72976-018-01 Er Hemorrhoids Cream

72976-018-01 Er Hemorrhoids Cream
SPL v1
SPL
SPL Set ID 3cf29fc0-af4d-4610-a426-894601d5e078
Route
RECTAL
Published
Effective Date 2024-02-02
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
Cetostearyl Alcohol Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-02

Description

Mineral Oil                   14% Petrolatum                   74.9%  Phenylephrine HCI        0.25% 

Purpose

Protectant Protectant Vasoconstrictor


Medication Information

Purpose

Protectant

Protectant

Vasoconstrictor

Description

Mineral Oil                   14% Petrolatum                   74.9%  Phenylephrine HCI        0.25% 

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 50566-9

Stop use and ask a doctor if

  • 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 productdo not exceed the recommended daily dosage unless directed by a doctor

Section 50568-5

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

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
Section 51945-4

Section 53414-9

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

Warnings

For external use only.

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 secured on tube
  • 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, lubricate 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 provides continual therapy for relief of symptoms
  • children under 12 years of age: ask a doctor

Other Information
  • store at 20°-25°C (68°-77°F)
  • do not use if tube seal under cap is broken
Active Ingredients

Mineral Oil                   14%

Petrolatum                   74.9% 

Phenylephrine HCI        0.25% 

Inactive Ingredients

beeswax, ceteareth-20, cetostearyl alcohol, glycerin

Keep Out of Reach of Children

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


Structured Label Content

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 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 the rectum causes additional pain
Section 50567-7 (50567-7)

When using this productdo not exceed the recommended daily dosage unless directed by a doctor

Section 50568-5 (50568-5)

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

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
Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Purpose

Protectant

Protectant

Vasoconstrictor

Warnings

For external use only.

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 secured on tube
  • 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, lubricate 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 provides continual therapy for relief of symptoms
  • children under 12 years of age: ask a doctor

Other Information
  • store at 20°-25°C (68°-77°F)
  • do not use if tube seal under cap is broken
Active Ingredients

Mineral Oil                   14%

Petrolatum                   74.9% 

Phenylephrine HCI        0.25% 

Inactive Ingredients

beeswax, ceteareth-20, cetostearyl alcohol, glycerin

Keep Out of Reach of Children (Keep out of reach of children)

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


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Raw Label Data

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