Otc - Active Ingredient
Lidocaine HCl 5%, Phenylephrine HCl 0.25%, Witch Hazel 50%
Lidocaine Hemorrhoid Spray
FDA Label NDC 0363-1657
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens Co for the product Lidocaine Hemorrhoid (NDC 0363-1657). 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
Anorectal; anesthetic, vasoconstrictor, astringent
Indications & Usage
- Temporarily shrinks hemorrhoidal tissue
- Temporarily reduces the swelling and irritation associated with hemorrhoids and other anorectal disorders
- aids in protecting irritated anorectal areas
Temporarily shrinks hemorrhoidal tissue. Temporarily reduces the swelling and irritation associated with hemorrhoids and other anorectal disorders. Aids in protecting irritated anorectal areas.
Warnings
For external use only.
Flammable. Do not use while smoking or near heat or flame.
When using this product
- keep away from children
- avoid spraying in eyes
- contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120F
- do not exceed the recommended daily dosage unless directed by a doctor
- 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 symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.
- heart disease, high blood pressure, thyroid disease, diabetes, difficulty in urination due to enlargement of the prostate gland
- are presently taking a prescription drug for high blood pressure or depression
- bleeding occurs
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
- needed for longer than 1 week
Ask a doctor or pharmacist before use if you have
Stop use and ask a doctor if
Otc - Pregnancy Or Breast Feeding
Ask a health professional before use.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).
Dosage & Administration
- Adults: when practical, cleanse the affected are with an appropriate cleansing wipe.
- Spray rectal area until thoroughly moist. Wipe off excess with tissue.
- Gently dry by patting or blotting with a tissue or a soft cloth.
- Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.
- Children under 12 years of age, consult a doctor.
Inactive Ingredient
alcohol, aloe barbadensis leaf extract, anthemis nobilis flower extract, benzophenone-4, benzyl alcohol, centella asiatica extract,disodium EDTA, epilobium angustifolium extract, ethylhexylglycerin, glycerin, hydroxyethylcellulose, polysorbte 40, propylene glycol, sodium citrate, tocopherol, tocopheryl acetate, water.
Otc - Questions
1-800-925-4733
* Please review the disclaimer below.
