Otc - Active Ingredient
Active Ingredients Purpose
Lidocaine 5% ………………………………………….Local Anesthetic
Phenylephrine HCl 0.25% ………………………….....Vasoconstrictor
Numb520spray Liquid
FDA Label NDC 72654-037
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ebanel Laboratories, Inc. for the product Numb520spray (NDC 72654-037). 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, indications & usage, warnings, dosage & administration, otc - keep out of reach of children, inactive ingredient, otc - purpose, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Uses
■ For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders and anorectal inflammation.
■ For the temporary relief of pain, burning and soreness.
■ Temporarily shrinks hemorrhoidal tissue.
■ Temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders.
Warnings
Warnings
■ If condition worsens or does not improve within 7 days, consult a doctor.
■ Do not exceed the recommended daily dosage unless directed by a doctor.
■ In case of bleeding, consult a doctor promptly.
■ Do not put this product into the rectum by using fingers or any mechanical device or applicator.
■ Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.
■ Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.
■ Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.
Dosage & Administration
Directions
■ Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Children under 12 years of age: consult a doctor.
■ Apply externally to the affected area up to 4 times daily.
Otc - Keep Out Of Reach Of Children
Other Information
■ Keep away from direct sunlight or heat.
■ Store at room temperature 15°-30°C (59°-86°F).
■ This package is child-resistant. Keep out of reach of children.
■ In case of accidental overdose or ingestion, call a doctor or poison control center immediately.
■ Do not use this product if seal is broken or missing.
Inactive Ingredient
Inactive Ingredients
Alcohol, Allantoin, Aloe Barbadensis Leaf Juice, Arginine Hydrochloride, Benzyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Disodium EDTA, Ethoxydiglycol, Glycerin, Hamamelis Virginiana (Witch Hazel) Water, Polysorbate 20, Propylene Glycol, Sodium Benzoate, Sodium Chloride, Sodium Citrate, Sodium Hydroxide, Sodium Metabisulfite, Sodium Sulfite, Water
Otc - Purpose
Purpose………………………………………….Local Anesthetic
Package Label.Principal Display Panel
Numb 520 Spray (Otc Label Numb520spray 2.4oz)
SPRAY
5% Lidocaine
0.25% Phenylephrine HCl
CHILD-RESISTANT PACKAGING
Topical Anorectal Spray
2.4 fl.oz e 72 mL
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