Max Strenth Pain Relief Hemorrhoidal Cream

Max Strenth Pain Relief Hemorrhoidal Cream
SPL v4
SPL
SPL Set ID 85a51d5c-679e-1959-e053-2a91aa0a76d5
Route
TOPICAL
Published
Effective Date 2019-04-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pramoxine (0.28 g) Glycerin (4.032 g) Phenylephrine (0.07 g) Petrolatum (4.2 g)
Inactive Ingredients
Propylene Glycol Propylparaben Glyceryl Monostearate Stearic Acid Methylparaben Polysorbate 80 Xanthan Gum Water Carboxymethylcellulose Sodium Aloe Vera Leaf Cetyl Alcohol Paraffin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-30

Description

Glycerin 14.4% Phenylephrine HCl 0.25% Pramoxine HCl 1% White petrolatum 15%

Purpose

Protectant Vasoconstrictor Local anesthetic Protectant


Medication Information

Purpose

Protectant

Vasoconstrictor

Local anesthetic

Protectant

Description

Glycerin 14.4% Phenylephrine HCl 0.25% Pramoxine HCl 1% White petrolatum 15%

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

For external use only.

Directions

Adults:

Children under 12 years of age: consult a doctor.

  • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
  • apply externally to the affected area up to 4 times daily, especially at night or in the morning or after each bowel movement.
  • apply externally or in the lower portion of the anal canal only.
  • 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.
Questions?

1-800-639-3803 Weekdays 9 AM to 4 PM EST

Other Information

store at room temperature 68° - 77° F (20° - 25° C).

Active Ingredients

Glycerin 14.4%

Phenylephrine HCl 0.25%

Pramoxine HCl 1%

White petrolatum 15%

Section Type Change

The section type INSTRUCTIONS FOR USE SECTION has been updated to DOSAGE & ADMINISTRATION SECTION. The information within the section stays the same.

Inactive Ingredients

aloe barbadensis leaf extract, carboxymethylcellulose sodium, cetyl alcohol, glyceryl monostearate, methylparaben, paraffin, propylene glycol, propylparaben, stearic acid, tween 80, water, xanthan gum

When Using This Product
  • do not put this product into the rectum by using fingers or any mechanical device or applicator
  • do not exceed recommended daily dosage unless directed by a doctor
Package Type 70000 0425 1

Stop Use and Ask A Doctor If
  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • the symptoms being treated do not subside or if redness, irritation, swelling, pain or other symptoms develop or increase. Some people can develop allergic reactions to ingredients in this product.
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are

presently taking a prescription drug for high blood pressure or depression.


Structured Label Content

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

Protectant

Vasoconstrictor

Local anesthetic

Protectant

Warnings

For external use only.

Directions

Adults:

Children under 12 years of age: consult a doctor.

  • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
  • apply externally to the affected area up to 4 times daily, especially at night or in the morning or after each bowel movement.
  • apply externally or in the lower portion of the anal canal only.
  • 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.
Questions?

1-800-639-3803 Weekdays 9 AM to 4 PM EST

Other Information

store at room temperature 68° - 77° F (20° - 25° C).

Active Ingredients (Active ingredients)

Glycerin 14.4%

Phenylephrine HCl 0.25%

Pramoxine HCl 1%

White petrolatum 15%

Section Type Change (Section Type change)

The section type INSTRUCTIONS FOR USE SECTION has been updated to DOSAGE & ADMINISTRATION SECTION. The information within the section stays the same.

Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf extract, carboxymethylcellulose sodium, cetyl alcohol, glyceryl monostearate, methylparaben, paraffin, propylene glycol, propylparaben, stearic acid, tween 80, water, xanthan gum

When Using This Product (When using this product)
  • do not put this product into the rectum by using fingers or any mechanical device or applicator
  • do not exceed recommended daily dosage unless directed by a doctor
Package Type 70000 0425 1 (Package type 70000-0425-1)

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
  • the symptoms being treated do not subside or if redness, irritation, swelling, pain or other symptoms develop or increase. Some people can develop allergic reactions to ingredients in this product.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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

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

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 urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

presently taking a prescription drug for high blood pressure or depression.


Advanced Ingredient Data


Raw Label Data

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