Dermend Moisturizing Anti-itch Lotion
FDA Label NDC 0496-0586

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 Dermend Moisturizing Anti-itch (NDC 0496-0586). 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, stop use and ask a doctor if, keep out of reach of children., directions, inactive ingredients, 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

external analgesic

Use

for the temporary relief of itching associated with minor skin irritations

Warnings

For external use only.

Avoid contact with the eyes.

Stop Use And Ask A Doctor If

  • conditions worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of Children.

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

Directions

  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 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

NDC 0496-0586-08

8oz (237mL)

Dermendbottlelabel (Dermendbottlelabel)

Dermendbottlelabel (Dermendbottlelabel)

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