Puregen Labs Maximum Strength Lidocaine Cream
FDA Label NDC 80513-813

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advanced Rx Llc for the product Puregen Labs Maximum Strength Lidocaine (NDC 80513-813). 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 ingredients, purpose, uses, warnings:, do not, 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

Drug Facts

Active Ingredients

Lidocaine 5.00 %

Purpose

Anorectal (hemorrhoidal)

Uses

  • Helps relieve the local itching and discomfort in the perianal area 
  • For the temporary relief of pain, irritation” or burning.

Warnings:

For external use only

Do Not

  • exceed the recommended daily dosage unless directed by a doctor. 
  • put this product into the rectum by using fingers or any mechanical device or applicator.

When Using This Product

  • If the condition worsens or does not improve within 7 days, consult a doctor. 
  • In case of bleeding, consult a doctor promptly.

Stop Use And Ask A Doctor If

  • If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.

    • Allergy alert 

    • Certain persons can develop allergic reactions to ingredients in this product.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast-Feeding,

ask a health professional before use

Directions:

Adults:

  • When practical, cleanse the affected area “with mild soap and warm water and rinse by patting or blotting with an appropriate cleansing pad 
  • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. 
  • Children under 12 years of age: consult a doctor. 
  • Apply externally to the affected area up to 6 times daily or after each bowel movement.

Other Information:

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzyl Alcohol, Carbomer, Dimethyl Isosorbide, Ethylhexylglycerin, Ethylhexyl Stearate, Hydrogenated Polyisobutene, Lecithin, Phenoxyethanol, Propylene Glycol, Sodium Polyacrylate, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Trideceth-6

Questions?

call toll-free 1-800-630-8895

Package Labeling:

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