Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 699310e8-1a93-40b4-a8f4-a765be4a0cb1
Route
TOPICAL
Published
Effective Date 2023-01-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (150 mg) Phenylephrine (2.5 mg) Glycerin (144 mg) Lidocaine (50 mg)
Inactive Ingredients
Butylated Hydroxyanisole Carboxymethylcellulose Sodium, Unspecified Cetyl Alcohol Citric Acid Monohydrate Dexpanthenol Edetate Disodium Glyceryl Monostearate Methylparaben Mineral Oil Laureth-23 Steareth-2 Steareth-20 Propyl Gallate Propylene Glycol Propylparaben Water Sodium Benzoate Stearyl Alcohol Tocopherol .alpha.-tocopherol Acetate Xanthan Gum Aloe Vera Leaf Anhydrous Citric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-11-01

Description

Glycerin 14.4% Lidocaine 5% Phenylephrine HCl 0.25% White petrolatum 15%

Purpose

Protectant Local anesthetic Vasoconstrictor Protectant


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

  • for temporary relief of pain, soreness and burning
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue
  • temporarily provides a coating for relief of anorectal discomforts
  • temporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful
Purpose

Protectant Local anesthetic Vasoconstrictor Protectant

Dosage and Administration

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 this cream.
  • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • children under 12 years of age: ask a doctor
Description

Glycerin 14.4% Lidocaine 5% Phenylephrine HCl 0.25% White petrolatum 15%

Section 44425-7

Other information

store at 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 right away.

Section 50566-9

Stop use and ask a doctor if

  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • an allergic reaction develops
  • the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase
Section 50567-7

When using this product

  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator
Section 50568-5

Ask a doctor or pharmacist before use if you arepresently 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 51727-6

Inactive ingredients

aloe barbadensis leaf extract, anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, dexpanthenol, edetate disodium, glyceryl monostearate, methylparaben, mineral oil, polyoxyl lauryl ether, polyoxyl stearyl ether, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, stearyl alcohol, tocopherols excipient, vitamin E acetate, xanthan gum

Section 53413-1

Questions or comments?

Call weekdays 9 AM to 5 PM EST at 1-800-99PrepHor 1-800-997-7374

Section 53414-9

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

Purposes

Protectant

Local anesthetic

Vasoconstrictor

Protectant

Active Ingredients

Glycerin 14.4%

Lidocaine 5%

Phenylephrine HCl 0.25%

White petrolatum 15%

Principal Display Panel

PREPARATION H ®

New Benefit

Now Reduces Swelling

See new label

RAPID RELIEF

WITH

LIDOCAINE

HEMORRHOIDAL

CREAM

LIDOCAINE

PHENYLEPHRINE HCl

GLYCERIN

WHITE PETROLATUM

5%

HIGHEST STRENGTH

LIDOCAINE

AVAILABLE

  • Rapid numbing relief of pain,

    itching & burning
  • Reduces swelling & provides

    a soothing protective layer

1 TUBE | NET WT 0.75 OZ (23 g)


Structured Label Content

Indications and Usage (34067-9)

Uses

  • for temporary relief of pain, soreness and burning
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue
  • temporarily provides a coating for relief of anorectal discomforts
  • temporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful
Dosage and Administration (34068-7)

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 this cream.
  • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • children under 12 years of age: ask a doctor
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

store at 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 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
  • an allergic reaction develops
  • the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase
Section 50567-7 (50567-7)

When using this product

  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you arepresently 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 51727-6 (51727-6)

Inactive ingredients

aloe barbadensis leaf extract, anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, dexpanthenol, edetate disodium, glyceryl monostearate, methylparaben, mineral oil, polyoxyl lauryl ether, polyoxyl stearyl ether, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, stearyl alcohol, tocopherols excipient, vitamin E acetate, xanthan gum

Section 53413-1 (53413-1)

Questions or comments?

Call weekdays 9 AM to 5 PM EST at 1-800-99PrepHor 1-800-997-7374

Section 53414-9 (53414-9)

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

Purposes

Protectant

Local anesthetic

Vasoconstrictor

Protectant

Active Ingredients

Glycerin 14.4%

Lidocaine 5%

Phenylephrine HCl 0.25%

White petrolatum 15%

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

PREPARATION H ®

New Benefit

Now Reduces Swelling

See new label

RAPID RELIEF

WITH

LIDOCAINE

HEMORRHOIDAL

CREAM

LIDOCAINE

PHENYLEPHRINE HCl

GLYCERIN

WHITE PETROLATUM

5%

HIGHEST STRENGTH

LIDOCAINE

AVAILABLE

  • Rapid numbing relief of pain,

    itching & burning
  • Reduces swelling & provides

    a soothing protective layer

1 TUBE | NET WT 0.75 OZ (23 g)


Advanced Ingredient Data


Raw Label Data

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