Other
Drug Facts
Hemorrhoidal
FDA Label NDC 71003-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Purity Products for the product Hemorrhoidal (NDC 71003-001). 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 other, otc - purpose, uses, warnings, ask a doctor before use if you have, otc - ask doctor/pharmacist, 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.
Label Section Quick Index
Otc - Purpose
| Active Ingredients | Purposes |
|---|---|
| Glycerin 14.4% | Protectant |
| Phenylephrine HCl 0.25% | Vasoconstrictor |
| Pramoxine HCl 1% | Local Anesthetic |
| White petrolatum 15% | Protectant |
Uses
- For temporary relief of pain, soreness and burning
- Helps relieve the local itching and discomfort associated with hemorrhoids
- Temporarily shrinks hemorrhoidal tissue and relieves burning
- Temporarily provides a coating for relief of anorectal discomforts
- Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
Warnings
For external use only
Ask A Doctor Before Use If You Have
- Heart disease
- High blood pressure
- Thyroid disease
- Diabetes
- Difficulty urinating due to enlargement of the prostate gland
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking a prescription drug for high blood pressure or depression
When Using This Product
- 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
Stop Use And Ask A Doctor If
- Bleeding occurs the 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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- 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 soft cloth before applying the cream
- When first opening the tube, remove the foil seal
- Apply externally or in the lower portion of the anal canal only
- Apply externally 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 the cover from the dispensing cap. Attach the dispensing cap to the tube. Lubricate the dispensing cap well, then gently insert the dispensing cap partway into the anus.
- Thoroughly cleanse the dispensing cap after each use, and replace the cover
- Children under 12 years: ask a doctor
Other Information
- Store at 15 to 30°C (59 to 86°F)
Inactive Ingredient
Aloe barbadensis leaf extract, anhydrous citric acid, butylated hydroxyanisole, cetyl alcohol, edetate disodium, glyceryl monostearate, laureth-23, methylparaben, mineral oil, panthenol, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, sodium carboxymethyl cellulose, steareth-2, steareth-20, stearyl alcohol, vitamin E acetate, xanthan gum
Questions Or Comments?
To Reorder Call: 1-800-281-7781, Customer Care: 1-888-769-7873 or www.purityproducts.com
Principal Display Panel - 25.5 G Tube Carton
NET WT.
0.9 OZ (25.5 G)
Save
Uranus
RAPID
SOOTHING
Relief & Comfort
MAXIMUM STRENGTH FOR PAINFUL
BURNING, ITCHING, & DISCOMFORT.
Principal Display Panel (25.5 G Tube Carton)
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