Hemorrhoidal Cream

Hemorrhoidal Cream
SPL v1
SPL
SPL Set ID fe25bc32-e37a-45ab-887c-f0332b6cf990
Route
TOPICAL
Published
Effective Date 2016-10-25
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 Butylated Hydroxyanisole Cetyl Alcohol Citric Acid Monohydrate Edetate Disodium Anhydrous Glyceryl Monostearate Laureth-23 Methylparaben Mineral Oil Panthenol Propyl Gallate Propylene Glycol Propylparaben Sodium Benzoate Carboxymethylcellulose Sodium, Unspecified Form Steareth-2 Steareth-20 Stearyl Alcohol .alpha.-tocopherol Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-10-20

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • For temporary relief of pain, soreness and burning
  • 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 42229-5

Drug Facts

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 are taking a prescription drug for high blood pressure or depression

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
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 soft cloth before applying the cream
  • When first opening the tube, remove the foil seal
  • 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 the cover from the dispensing cap. Attach the dispensing cap to the tube. Lubricate the dispensing cap well, then gently insert the dispensing cap partway into the anus.
  • Thoroughly cleanse the dispensing cap after each use, and replace the cover
  • Children under 12 years: ask a doctor
Other Information
  • Store at 15 to 30°C (59 to 86°F)
Inactive Ingredient

Aloe barbadensis leaf extract, anhydrous citric acid, butylated hydroxyanisole, cetyl alcohol, edetate disodium, glyceryl monostearate, laureth-23, methylparaben, mineral oil, panthenol, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, sodium carboxymethyl cellulose, steareth-2, steareth-20, stearyl alcohol, vitamin E acetate, xanthan gum

Questions Or Comments?

To Reorder Call: 1-800-281-7781, Customer Care: 1-888-769-7873 or www.purityproducts.com

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 the 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 urinating due to enlargement of the prostate gland
Principal Display Panel 25.5 G Tube Carton

NET WT.

0.9 OZ (25.5 G)

Save

Uranus

RAPID

SOOTHING


Relief & Comfort

MAXIMUM STRENGTH FOR PAINFUL

BURNING, ITCHING, & DISCOMFORT.


Structured Label Content

Uses
  • For temporary relief of pain, soreness and burning
  • 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 42229-5 (42229-5)

Drug Facts

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 are taking a prescription drug for high blood pressure or depression

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
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 soft cloth before applying the cream
  • When first opening the tube, remove the foil seal
  • 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 the cover from the dispensing cap. Attach the dispensing cap to the tube. Lubricate the dispensing cap well, then gently insert the dispensing cap partway into the anus.
  • Thoroughly cleanse the dispensing cap after each use, and replace the cover
  • Children under 12 years: ask a doctor
Other Information
  • Store at 15 to 30°C (59 to 86°F)
Inactive Ingredient

Aloe barbadensis leaf extract, anhydrous citric acid, butylated hydroxyanisole, cetyl alcohol, edetate disodium, glyceryl monostearate, laureth-23, methylparaben, mineral oil, panthenol, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, sodium carboxymethyl cellulose, steareth-2, steareth-20, stearyl alcohol, vitamin E acetate, xanthan gum

Questions Or Comments? (Questions or comments?)

To Reorder Call: 1-800-281-7781, Customer Care: 1-888-769-7873 or www.purityproducts.com

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 the 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 urinating due to enlargement of the prostate gland
Principal Display Panel 25.5 G Tube Carton (PRINCIPAL DISPLAY PANEL - 25.5 G Tube Carton)

NET WT.

0.9 OZ (25.5 G)

Save

Uranus

RAPID

SOOTHING


Relief & Comfort

MAXIMUM STRENGTH FOR PAINFUL

BURNING, ITCHING, & DISCOMFORT.


Advanced Ingredient Data


Raw Label Data

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