Dermarest Lotion
FDA Label NDC 63736-339

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Insight Pharmaceuticals Llc for the product Dermarest (NDC 63736-339). 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, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

temporary relief of itching associated with

  • minor skin irritations
  • inflammation
  • rashes due to eczema

    • Other uses of this product should be only under the advice and supervision of a doctor.

Warnings

For external use only

Do Not Use

for the treatment of diaper rash

When Using This Product

do not get into the eyes.

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

    • Do not begin use of any other hydrocortisone product unless you have consulted a doctor.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

adults and children 2 years of age and olderapply to affected area not more than 3 to 4 times daily
children under 2 years of agedo not use, consult a doctor

Other Information

  • shake well
  • store at room temperature 15° - 25°C (59°- 77°F)

Inactive Ingredients

Purified water, propylene glycol, glycerin, cetyl alcohol, glyceryl stearate, dimethicone, aleurites moluccana seed oil, zinc PCA, panthenol, carthamus tinctorius (safflower) flower extract, camellia sinensis leaf extract, rheum palmatum root/stalk extract, cyclohexasiloxane, cyclopentasiloxane, xanthan gum, disodium edetate, sodium hydroxide, diazolidinyl urea, methylparaben, propylparaben

Questions?

1-800-344-7239 www.Dermarest.com

Principal Display Panel

Dermarest®

Eczema
Medicated
Lotion

Hydrocortisone 1%
Anti-Itch Lotion
4 FL OZ (118 mL)

Principal Display Panel Dermarest®eczemamedicatedlotionhydrocortisone 1%anti-itch Lotion4 Fl Oz (118 mL) (Dermarest Eczema Medicated Lotion 01)

Principal Display Panel Dermarest®eczemamedicatedlotionhydrocortisone 1%anti-itch Lotion4 Fl Oz (118 mL) (Dermarest Eczema Medicated Lotion 01)

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