Otc - Active Ingredient
Lidocaine 4%, Phenylephrine HCl 0.25%
Dr Butlers Hemorrhoid And Fissure Pf Ointment
FDA Label NDC 70942-357
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Beyond Health P.a. for the product Dr Butlers Hemorrhoid And Fissure Pf (NDC 70942-357). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Analgesic (pain relief), Vasoconstrictor
Indications & Usage
Temporarily shrinks hemorrhoidal tissue, for the temporary relief of pain, soreness, or burning, and helps relieve the local itching and discomfort associated with hemorrhoids.
Warnings
For external use only including the skin of the anal canal.
When using this product do not exceed recommended daily dosage unless directed by a doctor, when using finger cots or an applicator, apply externally or the skin of the anal canal only. Do not put this product into the rectum.
Ask a doctor before use if you have allergies to any of the components of this product, difficulty in urination due to enlargement of the prostate gland, diabetes, heart disease, high blood pressure, thyroid disease, or presently taking a prescription for high blood pressure or depression.
Stop use and ask a doctor if condition worsens or does not improve within seven days, bleeding occurs, an allergic reaction develops, the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.
Otc - Keep Out Of Reach Of Children
If swallowed, seek medical help or contact a Poison Control Center right away.
Dosage & Administration
Children under 12 years of age consult your pediatrician.
Adults: apply to affected area up to 3 times daily.
Clean affected area with mild soap and warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth before use.
To use dispensing cap, attach it to tube, lubricate well then gently insert part way into anus and squeeze tube to deliver medication. Thoroughly cleanse dispensing cap after use with mild soap and warm water and rinse thoroughly.
Inactive Ingredient
Aesculus hippocastanum (horse chestnut) extract, aloe barbadensis leaf extract, ascorbic acid, calendula officinalis flower extract, caprylhydroxamic acid, caprylic/capric triglyceride, centella asiatica extract, chamomile recutita (matricaria) flower extract, cholecalciferol, glycerin, glyceryl caprylate, helianthus annuus (sunflower) seed oil, hydrocortisone, laminaria digitata (algae) extract, lysine HCl, mineral oil, octyldodecanol, olea europaea (olive) fruit oil, panax ginseng root extract, PEG-8 dimehticone, petrolatum, porphyria umbilicalis extract, propylene glycol, punica granatum fruit extract, pyridoxine HCl, retinyl palmitate, silica, sodium hyaluronate, sodium propoxyhydroxypropyl thiosulfate silica, stearic acid, tocopheryl acetate, triethoxycaprylysilance, water, zea mays (corn) oil, zinc oxide
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health care professional before use.
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