Lidocaine Anorectal Cream
FDA Label NDC 39328-025

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Patrin Pharma, Inc for the product Lidocaine Anorectal (NDC 39328-025). 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, active ingredient, purpose, uses, warnings, stop use and ask a doctor if, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Lidocaine 5% w/w

Purpose

Local anesthetic

Uses

Temporarily relieves pain and itching due to anorectal disorders

Warnings

When using this product

  • Avoid contact with eyes
  • Do not exceed recommended dosage unless directed by a doctor

Stop Use And Ask A Doctor If

  • Rectal bleeding occurs
  • Condition worsens or does not improve within 7 days
  • Allergic reaction occurs
  • Redness, irritation, swelling, pain or other symptoms begin or increase
  • Symptoms clear up and return within a few days

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

  • When practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
  • Adults and children 12 years and older: Apply externally to the affected area up to 6 times a day.
  • Children under 12 years of age: Consult a doctor

Other Information

  • Store at room temperature 20–25°C (68–77°F); Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature].

Inactive Ingredients

Benzyl Alcohol, Carbopol 940, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine, and Vitamin E Acetate

Questions?

Call 800-936-3088

Principal Display Panel - 15 Gram Tube Carton

NDC 39328-025-15

Lidocaine
5%
Anorectal Cream

PATRIN
PHARMA

NET WT. 15 grams

Principal Display Panel (15 gram Tube Carton)

Principal Display Panel (15 gram Tube Carton)

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