Preparation H ®

Preparation H ®
SPL v18
SPL
SPL Set ID 7cc03d2e-e708-589a-d9bb-58ebbda989c0
Route
TOPICAL
Published
Effective Date 2021-03-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (144 mg) Phenylephrine (2.5 mg) Pramoxine (10 mg) Petrolatum (150 mg)
Inactive Ingredients
Aloe Vera Leaf .alpha.-tocopherol Acetate Anhydrous Citric Acid Butylated Hydroxyanisole Carboxymethylcellulose Sodium, Unspecified Cetyl Alcohol Citric Acid Monohydrate Dexpanthenol Edetate Disodium Glyceryl Monostearate Laureth-23 Methylparaben Mineral Oil Propyl Gallate Propylene Glycol Propylparaben Sodium Benzoate Stearyl Alcohol Water Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2004-07-01

Description

Drug Facts


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
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 cream.
  • when first opening the tube, puncture foil seal with top end of cap
  • apply externally or in the lower portion of the anal canal only
  • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • for application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus.
  • thoroughly cleanse dispensing cap after each use and replace cover
  • children under 12 years of age: ask a doctor
Description

Drug Facts

Section 42229-5

Drug Facts

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 50568-5

Ask a doctor or pharmacist before use if you arepresently taking a prescription drug for high blood pressure or depression.

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 1-800-99PrepH or 1-800-997-7374

Section 53414-9

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

Section 55105-1
Active ingredients Purposes

Glycerin 14.4%

Protectant

Phenylephrine HCl 0.25%

Vasoconstrictor

Pramoxine HCl 1%

Local anesthetic

White petrolatum 15%

Protectant

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
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
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
Principal Display Panel 26 G Tube Carton

PREPARATION H ®

HEMORRHOIDAL

CREAM

Multi-Symptom

Pain Relief

WITH

ALOE

New Look,

SAME SIZE!

  • Soothing Pain Relief from Burning,

    Itching, & Discomfort
  • Shrinks Swollen Hemorrhoidal Tissue
  • Protects Irritated Tissue
  • Relieves External Discomfort
  • Proprietary Blend with Vitamin E

    and Aloe

1 TUBE | NET WT 0.9 OZ (26 g)

Principal Display Panel 51 G Tube Carton

PREPARATION H ®

HEMORRHOIDAL CREAM

Maximum Strength Pain Relief

Smooth Cream

Formula with Aloe

  • Rapid, Soothing Pain Relief from Painful

    Burning, Itching and Discomfort
  • Shrinks Swollen Hemorrhoidal Tissue
  • Protects Irritated Tissue
  • Relieves External Discomfort

NET WT. 1.8 OZ (51 g)

Principal Display Panel 51 G Tube Carton Ndc 0573 2868 98

PREPARATION H ®

HEMORRHOIDAL

CREAM

Multi-Symptom

Pain Relief

WITH

ALOE

  • Soothing Pain Relief from Burning,

    Itching, & Discomfort
  • Shrinks Swollen Hemorrhoidal Tissue
  • Protects Irritated Tissue
  • Relieves External Discomfort
  • Proprietary Blend with Vitamin E

    and Aloe

1 TUBE | NET WT 1.8 OZ (51 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 cream.
  • when first opening the tube, puncture foil seal with top end of cap
  • apply externally or in the lower portion of the anal canal only
  • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • for application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus.
  • thoroughly cleanse dispensing cap after each use and replace cover
  • children under 12 years of age: ask a doctor
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 42229-5 (42229-5)

Drug Facts

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 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 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 1-800-99PrepH or 1-800-997-7374

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients Purposes

Glycerin 14.4%

Protectant

Phenylephrine HCl 0.25%

Vasoconstrictor

Pramoxine HCl 1%

Local anesthetic

White petrolatum 15%

Protectant

When Using This Product (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
Stop Use and Ask A Doctor If (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
Ask A Doctor Before Use If You Have (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
Principal Display Panel 26 G Tube Carton (PRINCIPAL DISPLAY PANEL - 26 g Tube Carton)

PREPARATION H ®

HEMORRHOIDAL

CREAM

Multi-Symptom

Pain Relief

WITH

ALOE

New Look,

SAME SIZE!

  • Soothing Pain Relief from Burning,

    Itching, & Discomfort
  • Shrinks Swollen Hemorrhoidal Tissue
  • Protects Irritated Tissue
  • Relieves External Discomfort
  • Proprietary Blend with Vitamin E

    and Aloe

1 TUBE | NET WT 0.9 OZ (26 g)

Principal Display Panel 51 G Tube Carton (PRINCIPAL DISPLAY PANEL - 51 g Tube Carton)

PREPARATION H ®

HEMORRHOIDAL CREAM

Maximum Strength Pain Relief

Smooth Cream

Formula with Aloe

  • Rapid, Soothing Pain Relief from Painful

    Burning, Itching and Discomfort
  • Shrinks Swollen Hemorrhoidal Tissue
  • Protects Irritated Tissue
  • Relieves External Discomfort

NET WT. 1.8 OZ (51 g)

Principal Display Panel 51 G Tube Carton Ndc 0573 2868 98 (PRINCIPAL DISPLAY PANEL - 51 g Tube Carton - NDC 0573-2868-98)

PREPARATION H ®

HEMORRHOIDAL

CREAM

Multi-Symptom

Pain Relief

WITH

ALOE

  • Soothing Pain Relief from Burning,

    Itching, & Discomfort
  • Shrinks Swollen Hemorrhoidal Tissue
  • Protects Irritated Tissue
  • Relieves External Discomfort
  • Proprietary Blend with Vitamin E

    and Aloe

1 TUBE | NET WT 1.8 OZ (51 g)


Advanced Ingredient Data


Raw Label Data

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