Drug Facts - Active Ingredients
Glycerin 14.4%
Phenylephrine Hydrochloride 0.25%
Pramoxine Hydrochloride 1%
White petrolatum 15%
The following Structured Product Label (SPL) was submitted to the FDA by Neilmed Pharmaceuticals Inc. for the product Hemorrhoidal Pain Relief With Aloe And Vitamine (NDC 13709-324). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts - active ingredients, purpose, uses:, warnings:, ask a doctor before use if you have, ask a doctor or pharmacist before use, when using this product:, stop use and ask doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Glycerin 14.4%
Phenylephrine Hydrochloride 0.25%
Pramoxine Hydrochloride 1%
White petrolatum 15%
Glycerin 14.4% ..................................................................... Protectant
Phenylephrine Hydrochloride 0.25% ...............................Vasoconstrictor
Pramoxine Hydrochloride 1% ...................................... Local Anesthetic
White petrolatum 15% .......................................................... Protectant
��������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.
For external use only
��������Heart disease ��������High blood pressure ��������Thyroid disease ��������Diabetes��������Difficulty in urination due to enlargement of prostate gland.
if you are presently taking a prescription drug for high blood pressure or depression.
��������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
��������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, ask a health professional before use.
If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).
��������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.
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
Questions? 1 (877) 477-8633
TAMPER EVIDENT: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING
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.
swollen hemorrhoidal tissue, to get quick temporary relief from pain, burning, itching& irritation
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