Otc - Active Ingredient
Lidocaine 5%, Phenylephrine HCl 0.25%,
Dch Rapid Relief Hemorrhoidal Spray
FDA Label NDC 72839-263
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Derma Care Research Labs for the product Dch Rapid Relief Hemorrhoidal (NDC 72839-263). 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 - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Anesthetic, Vasoconstrictor
Indications & Usage
Helps relieve the local itching and discomfort associated with anorectal disorders or inflammation.
Warnings
For external use only.
Flammable--do not use while smoking or near heat or flame.
When using this product avoid contact with eyes, contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120F, do not exceed recommended daily dosage unless directed by a doctor, do not put this product in the rectum by using fingers or any mechanical device or applicator.
Ask a doctor before use if you have heart disease, high blood pressure, thyroid disease, diabetes, difficulty in urination due to enlargement of the prostate gland, presently taking a prescription for high blood pressure or depression.
Stop use and ask a doctor if rectal bleeding occurs, the condition worsens or symptoms does not improve within 7 days, allergic reaction occurs to ingredients in this product, symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.
Otc - Pregnancy Or Breast Feeding
Ask a healthcare or professional before use.
Otc - Keep Out Of Reach Of Children
If swallowed, seek medical help or contact a Poison Control Center right away.
Dosage & Administration
When practical, cleanse the affected area with mild soap and warm water, rinse thoroughly, and gently pat dry. Spray the affected area, wash hands after applying. Adults and children 12 years and older: apply externally to the affected area up to 6 times a day. Children under 12 years of age: consult a doctor.
Inactive Ingredient
Alcohol, Aloe Barbadensis Leaf Extract, Citric Acid, Disodium EDTA, Glycerin, Malic Acid, Menthol, Propyl Gallate, Propylene Glycol, Sodium Benzoate, Water.
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