Otc - Active Ingredient
Lidocaine 5%, Mineral Oil 17%, Phenylephrine HCl 0.25%, White Petrolatum 39%
Hemorrhoidal Cream
FDA Label NDC 0363-5223
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 Hemorrhoidal (NDC 0363-5223). 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
Hemorrhoidal (anorectal)
Indications & Usage
- helps relieve the pain, itching, and burning associated with hemorrhoids.
- temporarily reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders
- temporarily provides a coating for relief of anorectal discomforts
- temporarily protects irritate area on inflamed perianal skin
Warnings
For external use only.
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
Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.
When using this product avoid contact with eyes, do not exceed 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.
Stop use and ask a doctor if bleeding occurs, condition worsens or 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
If pregnant or breastfeeding, ask a doctor before use.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
- When practical, cleanse area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying
- Adults and children 12 years and older: apply externally to the affected are up to 4 times day
- Children under 12 years of age: consult a doctor
Inactive Ingredient
Ceteareth-20, cetostearyl alcohol, citric acid, ethylhexylglycerin, phenoxyethanol, water
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