Prax Lotion
FDA Label NDC 0496-0748

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ferndale Laboratories, Inc. for the product Prax (NDC 0496-0748). 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 active ingredient, purpose, use, warnings, do not, stop use and ask a doctor if, 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

Active Ingredient

pramoxine HCl 1% w/w

Purpose

local anesthetic

Use

for the temporary relief of discomfort and itch in the perianal area

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


Stop Use And Ask A Doctor If

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

Keep Out Of Reach Of Children.

If swallowed, seek medical attention or contact a Poison Control Center right away.

Directions

  • Shake well before use.
  • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.
  • Adults and children 12 years of age and older: apply to affected area up to 5 times daily.
  • Children under 12 years of age: consult a doctor.


Inactive Ingredients

cetyl alcohol, di-isopropyl adipate, dimethicone, glycerin, FORLAN-L (Contains: petrolatum, lanolin, hydrogenated coconut oil, sorbitan sesquioleate, stearyl alcohol, and cetyl alcohol), mineral oil, polyoxyl 40 stearate, potassium sorbate, povidone, purified water, sorbic acid, stearic acid, and trolamine

Package Label

Manufactured for
Ferndale Healthcare® Inc.
By Ferndale Laboratories, Inc.
Ferndale, MI 48220 U.S.A.
Toll Free (888) 548-0900
www.ferndalehealthcare.com

8 fl oz (237 mL) NDC 0496-0748-03

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