Otc - Active Ingredient
Glycerin 14.4%, Lidocaine 5%, Petrolatum 15%, Phenylephrine HCl 0.25%
Norms Hemorrhoid Cream
FDA Label NDC 85996-173
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 85996-173). 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/Hemorrhoidal
Indications & Usage
Helps relieve the pain, itching, and burning associated with hemorrhoids. Temporarily shrinks hemorrhoidal tissue. Temporarily provides a coating for relief of anorectal discomforts. Temporarily protects irritated areas and inflamed perineal skin.
Warnings
For external use only.
When using this product do not exceed recommended dosage unless directed by a doctor, do not put this product into rectum by using fingers or any mechanical device or applicator.
Ask a doctor or pharmacist before use if you have difficulty in urination due to enlargement of the prostate gland, diabetes, heart disease, high blood pressure, thyroid disease, or you are presently taking a prescription for high blood pressure or depression.
Stop use and ask a doctor if condition worsens or does not improve within seven days, if bleeding occurs.
Otc - Pregnancy Or Breast Feeding
Ask a health care 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
Adults: apply up to 3 times daily or after each bowl movement. 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 soft cloth before each application of this product. To use finger gots: roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area.
Children under 12 years of age: consult your pediatrician.
Inactive Ingredient
Aloe barbadensis leaf extract, BHA, cellulose gum, cetyl alcohol, citric acid, disodium EDTA, ethylhexylglycerin, glyceryl stearate, mineral oil, panthenol, Phenoxyethanol, propyl gallate, propylene glycol, sorbitan olivate, steareth-21, stearyl alcohol, tocopherol, tocopheryl acetate, water, xanthan gum.
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