simple promise simple h hemorrhoid relief cream

simple promise simple h hemorrhoid relief cream
SPL v2
SPL
SPL Set ID f6622caa-3b31-9b07-e053-2a95a90a8a51
Route
topical
Published
Effective Date 2022-06-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
phenylephrine (2.5 mg) pramoxine (10 mg)
Inactive Ingredients
water aloe vera leaf behentrimonium methosulfate shea butter calendula officinalis flower caprylyl glycol carbomer homopolymer, unspecified type cetostearyl alcohol cetyl alcohol cucumber decyl glucoside dimethicone glycerin glyceryl laurate glyceryl monostearate glycyrrhiza glabra hamamelis virginiana root bark/stem bark isopropyl myristate peg-100 stearate petrolatum polysorbate 20 sodium hydroxide stearic acid stearyl alcohol edetate sodium .alpha.-tocopherol acetate xanthan gum corn propanediol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-03-06

Purpose

Vasoconstrictor Local anesthetic

Description

Phenylephrine HCl 0.25% Pramoxine HCl 1%


Medication Information

Warnings

For external use only

Uses

• for temporary relief of pain, soreness and burning • helps relieve the local itching and discomfort associated with hemorrhoids • temporarily shrinks hemorrhoid 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

Vasoconstrictor

Local anesthetic

Directions

• : 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 Children under 12 years of age: ask a doctor. Adults





Other Information

• store at 20-25°C (68-77°F) • do not use if printed safety seal on cap is broken or missing

Inactive Ingredients

Aqua (Deionized Water), Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Behentrimonium Methosulfate, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Cetyl Alcohol, Cucumis Sativus (Cucumber) Extract, Decyl Glucoside, Dimethicone, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Glycyrrhiza Glabra (Licorice) Extract, Hamamelis Virginiana (Witch Hazel), Isopropyl Myristate, PEG-100 Stearate, Petrolatum, Polysorbate-20, Sodium Hydroxide, Stearic Acid, Stearyl Alcohol, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol.

Description

Phenylephrine HCl 0.25% Pramoxine HCl 1%

Do Not Use

this product if you have

• heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland • unless directed by a doctor.

Drug Facts

Active Ingredients

Phenylephrine HCl 0.25%

Pramoxine HCl 1%

When Using This Product

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

• attach the applicator to the tube. Lubricate the applicator well, then gently insert the applicator into the rectum. FOR INTRARECTAL USE:

In case of bleeding, consult a doctor promptly.

Stop Use and Ask A Doctor If

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

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 right away.

Ask A Doctor Or Pharmacist Before Use

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

Package Labeling: Simple Promise Simple H Hemorrhoid Relief Cream, 2oz/56.7g


Structured Label Content

Warnings

For external use only

Uses

• for temporary relief of pain, soreness and burning • helps relieve the local itching and discomfort associated with hemorrhoids • temporarily shrinks hemorrhoid 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

Vasoconstrictor

Local anesthetic

Directions

• : 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 Children under 12 years of age: ask a doctor. Adults





Other Information (Other information)

• store at 20-25°C (68-77°F) • do not use if printed safety seal on cap is broken or missing

Inactive Ingredients (Inactive ingredients)

Aqua (Deionized Water), Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Behentrimonium Methosulfate, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Cetyl Alcohol, Cucumis Sativus (Cucumber) Extract, Decyl Glucoside, Dimethicone, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Glycyrrhiza Glabra (Licorice) Extract, Hamamelis Virginiana (Witch Hazel), Isopropyl Myristate, PEG-100 Stearate, Petrolatum, Polysorbate-20, Sodium Hydroxide, Stearic Acid, Stearyl Alcohol, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol.

Do Not Use (Do not use)

this product if you have

• heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland • unless directed by a doctor.

Drug Facts

Active Ingredients (Active ingredients)

Phenylephrine HCl 0.25%

Pramoxine HCl 1%

When Using This Product (When using this product)

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

• attach the applicator to the tube. Lubricate the applicator well, then gently insert the applicator into the rectum. FOR INTRARECTAL USE:

In case of bleeding, consult a doctor promptly.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

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 right away.

Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)

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

Package Labeling: Simple Promise Simple H Hemorrhoid Relief Cream, 2oz/56.7g (Package Labeling: SIMPLE PROMISE Simple H Hemorrhoid Relief Cream, 2oz/56.7g)


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