Glycerin, Lidocaine, Petrolatum, And Phenylephrine Hydrochloride
FDA Label NDC 55629-051

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by One2zee Limited Liability Company for the product Glycerin, Lidocaine, Petrolatum, And Phenylephrine Hydrochloride (NDC 55629-051). 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 drug facts:, active ingredient:, purpose, uses:, warnings:, directions:, inactive ingredients:, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts:

Active Ingredient:

Glycerin 14.4%
Lidocaine 5%
Phenylephrine HCl 0.25%
White petrolatum 15%

Purpose

  • Protectant
  • Local anesthetic
  • Vasoconstrictor
  • Protectant

Uses:

  • 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

Warnings:

  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

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 4 times daily, especially at night, in the morning or after each bowel movement
  • Children under 12 years of age: ask a doctor

Inactive Ingredients:

aloe vera leaf, anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, dexpanthenol, edetate disodium, glyceryl monosterate, methylparaben, mineral oil, laureth-23, steareth-2, steareth-20, propyl gallate, propylene glycol, propylparaben, sodium benzoate, tocopherol, alpha.- tocopherol acetate, xanthan gum, water

Other Information:

Store at 20-25°C (68-77°F) Do not use if tamper evident packaging has been breached or is missing.

Distributed by: Wellspring Airmont, NY 10952 U.S.A.

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