Otc - Active Ingredient
Phenylephrine HCl 0.25%, Witch Hazel 50%
Norms Hemorrhoid Spray
FDA Label NDC 85996-135
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Totally Normal Company for the product Norms Hemorrhoid (NDC 85996-135). 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
Vasoconstrictor, Astringent
Indications & Usage
Temporarily reduces swelling associated with hemorrhoidal tissue. Temporary relief of anorectal itching and discomfort associated with hemorrhoids and other anorectal disorders.
Warnings
For external use only.
When using this product avoid spraying in 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 bleeding occurs, condition worsens or does not improve within 7 days.
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 immediately.
Dosage & Administration
Adults: when practical, cleanse the affected area with mild soap and warm water and pat dry. Spray the rectal area until thoroughly moist. Wipe off excess with a 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. For children under 12 years of age, consult a doctor.
Inactive Ingredient
Alcohol, Aloe Barbadensis Leaf Extract, Benzophenone-4, Benzyl Alcohol, Disodium EDTA, Ethylhexylglycerin, Hydroxyethylcellulose, Polysorbate 80, Propylene Glycol, Sodium Citrate, Tocopherol, Tocopheryl Acetate, Water.
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