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Drug Facts
For external use only
Hemorrhoidal
FDA Label NDC 76168-403
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Velocity Pharma Llc for the product Hemorrhoidal (NDC 76168-403). 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, indications & usage, warnings, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, otc - keep out of reach of children, 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 |
| Lidocaine 5% | Local anesthetic |
Indications & Usage
Uses
- for temporary relief of pain, soreness and burning
- helps relieve the local itching and discomfort associated with hemorrhoids
- temporarily provides a coating for relief of anorectal discomforts
- temporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful
Warnings
Warnings
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
- rectal 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
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.
Dosage & Administration
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 a soft cloth before applying this cream.
- apply externally to the affected area up to 6 times daily, especially at night, in the morning or after each bowel movement
- children under 12 years of age: ask a doctor
Storage And Handling
Other information
store at 20–25°C (68–77°F)
Inactive Ingredient
Inactive ingredients
aloe vera gel, anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, edetate disodium, glyceryl monostearate, methylparaben, mineral oil, polyoxyl lauryl ether, polyoxyl stearyl ether, propylene glycol, propylparaben, purified water, stearyl alcohol, white soft paraffin, xanthan gum
Otc - Questions
Questions or comments?
Call 888-309-9030
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Hemacream (Hemacream)
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