Active Ingredients
Glycerin 14.4%
Phenylephrine HCL 0.25%
Pramoxine HCl 1%
White petrolatum 15%
The following Structured Product Label (SPL) was submitted to the FDA by Unipack Llc for the product Avedana Hemorrhoidal (NDC 43749-470). 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 active ingredients, purpose, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Glycerin 14.4%
Phenylephrine HCL 0.25%
Pramoxine HCl 1%
White petrolatum 15%
Protectant
Vasoconstrictor
Local anasthetic
Protectant
-for temporary relief of pain, soreness, and burning.
-helps relieve the local itching and discomfort associated with hemorrhoids.
-temporarily shrinks hemorrhoidal tissue.
-temporarily provides a coating for relief of anorectal discomforts.
-temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful.
For external use only.
-heart disease
-high blood pressure
-thyroid disease
-diabetes
-difficulty in urination due to enlargement of the prostate gland
presently taking a prescription drug for high blood pressure or depression.
-do not exceed the recommended daily dosage unless directed by a doctor
-do not put into the rectum by using fingers or any mechanical device or applicator
-bleeding occurs
-condition worsens or does not improve within 7 days
-an allergic reaction develops
-the symptom being treated does not subside or if redness, irritation, swelling pain, or other symptoms develop or increase
ask a health professional before use.
If swallowed, get medical help or contact a Poison Control Center right away.
-adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying cream. When first opening the tube, puncture foil seal with top end of cap. Apply externally or in the lower portion of the anal canal only. Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.
-For application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubrcate dispensing cap well, then gently insert dispensing cap partway into the anus.
-thoroughly cleanse dispensing cap after each use and replace cover.
-children under 12 years of age: ask a doctor.
Apply externally or in the lower portion of the anal canal only. Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.
-For application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubrcate dispensing cap well, then gently insert dispensing cap partway into the anus.
store at 20-25oC (68-77oF)
Aloe barbadensis leaf extract, butylated hydroxytoluene, cetyl esters, cetyl palmitate, glyceryl monostearate, isopropyl myristate, lanolin, methylparaben, mineral oil, polysorbate 60, propylene glycol, propylparaben, sodium citrate, stearic acid, stearyl alcohol, vitamin E, water
Tube Label
0.9oz Carton Label
1.8oz Tube Label
1.8oz Carton Label
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