Curist Lidocaine Numbing Relief Cream
FDA Label NDC 72559-012

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Little Pharma, Inc. for the product Curist Lidocaine Numbing Relief (NDC 72559-012). 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 - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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Drug Facts

Distributed by:

Little Pharma, Inc.

New York, NY 10023

Made in USA With Globally Sourced Ingredients

Otc - Active Ingredient

Active ingredient

Lidocaine 5%

Otc - Purpose

Purpose

Anorectal (hemorrhoidal) cream

Indications & Usage

Uses

Helps relieve the pain, itching and burning associated with hemorrhoids and other anorectal disorders.

Warnings

Warnings

For external use only.

Otc - When Using

When using this product

  • avoid contact with eyes.
  • do not exceed recommended dosage unless directed by a doctor.
  • do not put this product into the rectum by using fingers or any mechanical device or applicator.

Otc - Stop Use

Stop use and ask a doctor if

  • rectal bleeding occurs.
  • condition worsens or does not improve within 7 days.
  • allergic reaction occurs to ingredients in this product.
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop 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.

Dosage & Administration

Directions

  • When practical, clean the affected 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.

Storage And Handling

Other information

Store at 15-30°C (59-86°F)

Inactive Ingredient

Inactive ingredients Benzyl alcohol, carbomer, cholesterol, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, tocopheryl acetate, triethanolamine, water.

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