Hemorrhoidal Pain Relief Cream With Aloe And Vitamin E

Hemorrhoidal Pain Relief Cream With Aloe And Vitamin E
SPL v1
SPL
SPL Set ID 076b5021-8ba0-0204-e063-6294a90a3337
Route
RECTAL
Published
Effective Date 2023-10-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (25 mg) Petrolatum (150 mg) Pramoxine (10 mg) Glycerin (144 mg)
Inactive Ingredients
Propylene Glycol Sodium Citrate Stearic Acid Water Mineral Oil Cetyl Palmitate Lanolin Methylparaben Butylated Hydroxytoluene Cetostearyl Alcohol Isopropyl Myristate Glyceryl Monostearate Propylparaben Aloe Polysorbate 60 Cetyl Esters Wax .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-11

Description

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

Purpose

Glycerin 14.4% ..................................................................... Protectant Phenylephrine Hydrochloride 0.25% ...............................Vasoconstrictor Pramoxine Hydrochloride 1% ...................................... Local Anesthetic White petrolatum 15% .......................................................... Protectant


Medication Information

Purpose



Glycerin 14.4% ..................................................................... Protectant

Phenylephrine Hydrochloride 0.25% ...............................Vasoconstrictor

Pramoxine Hydrochloride 1% ...................................... Local Anesthetic

White petrolatum 15% .......................................................... Protectant

Description

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

Use

swollen hemorrhoidal tissue, to get quick temporary relief from pain, burning, itching& irritation

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.

Important

Important: Please do not discard this printed box and any enclosed printed material. The inside final product may not have all the details you require for the ongoing use of the product.

Warnings:

For external use only

Questions?

Questions? 1 (877) 477-8633

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 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 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.

Tamper Evident:

TAMPER EVIDENT: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING

Inactive Ingredients:

aloe barbadensis leaf extract, butylated hydroxytoluene, cetostearyl alcohol, cetyl esters, cetyl palmitate, glyceryl monostearate, isopropyl myristate, lanolin, methylparaben, mineral oil, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearic acid, tocopherol acetate

When Using This Product:

􀁑􀀃Do not exceed the recommended daily dosage unless directed by a doctor

􀁑􀀃Do not put in the rectum by using fingers or any mechanical device or applicator

Package Label Outer Carton

Stop Use and Ask Doctor If:

􀁑􀀃Bleeding occurs 􀁑􀀃Condition worsens or does not improve within 7 days 􀁑􀀃An allergic reaction occurs 􀁑􀀃The symptom 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

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

Drug Facts Active Ingredients

Glycerin 14.4%

Phenylephrine Hydrochloride 0.25%

Pramoxine Hydrochloride 1%

White petrolatum 15%

Ask A Doctor Or Pharmacist Before Use

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

​ask A Doctor Before Use If You Have

􀁑􀀃Heart disease 􀁑􀀃High blood pressure 􀁑􀀃Thyroid disease 􀁑􀀃Diabetes􀁑􀀃Difficulty in urination due to enlargement of prostate gland.


Structured Label Content

Use

swollen hemorrhoidal tissue, to get quick temporary relief from pain, burning, itching& irritation

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



Glycerin 14.4% ..................................................................... Protectant

Phenylephrine Hydrochloride 0.25% ...............................Vasoconstrictor

Pramoxine Hydrochloride 1% ...................................... Local Anesthetic

White petrolatum 15% .......................................................... Protectant

Important

Important: Please do not discard this printed box and any enclosed printed material. The inside final product may not have all the details you require for the ongoing use of the product.

Warnings:

For external use only

Questions?

Questions? 1 (877) 477-8633

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 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 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.

Tamper Evident: (TAMPER EVIDENT:)

TAMPER EVIDENT: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING

Inactive Ingredients: (Inactive ingredients:)

aloe barbadensis leaf extract, butylated hydroxytoluene, cetostearyl alcohol, cetyl esters, cetyl palmitate, glyceryl monostearate, isopropyl myristate, lanolin, methylparaben, mineral oil, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearic acid, tocopherol acetate

When Using This Product: (When using this product:)

􀁑􀀃Do not exceed the recommended daily dosage unless directed by a doctor

􀁑􀀃Do not put in the rectum by using fingers or any mechanical device or applicator

Package Label Outer Carton (Package label _Outer carton)

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

􀁑􀀃Bleeding occurs 􀁑􀀃Condition worsens or does not improve within 7 days 􀁑􀀃An allergic reaction occurs 􀁑􀀃The symptom 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)

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 (1-800-222-1222).

Drug Facts Active Ingredients (Drug Facts - Active Ingredients)

Glycerin 14.4%

Phenylephrine Hydrochloride 0.25%

Pramoxine Hydrochloride 1%

White petrolatum 15%

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.

​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 prostate gland.


Advanced Ingredient Data


Raw Label Data

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