Dermagesic Cream
FDA Label NDC 54859-202

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Llorens Pharmaceutical International Division for the product Dermagesic (NDC 54859-202). 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 ingredients, purpose, uses, warnings, keep out of reach of children, directions, inactive ingredients, questions or comments, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Pramoxine HCl 1%

Zinc Oxide 0.4%

Calamine 0.4%

Purpose

Anestheric/Analgesic

Skin Protectant

Uses

  • for temporary reilef of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor irritation
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac.

Warnings

For external use only. Avoid contact with the eyes

  • Not for Pediatric use
  • Hypersensitivity to "caine" anesthetics

    • Do not use

    • on large areas of the body
    • with any other product containing diphenhydramine, even one taken by mouth.

      • Ask a doctor before use

      • on chicken pox
      • on measles

        • Stop use and ask a doctor if condition worsens or does not improve within 7 days

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

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

  • 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 ask a doctor
  • Do not use more often than directed

Inactive Ingredients

Aloe Badbadensis Leaf juice (Aloe Vera), Avena Sativa (Oat) Kernal colloidal, cetyl stearyl alcohol, ceteareth-6, ceteareth-25, diazolidinyl urea, fragrance, menthol, methyl paraben, paraffinum liquidum, propylene glycol, propyl paraben, purified water, stearyl alcohol

Questions Or Comments

1-866-595-5598

Package Label.Principal Display Panel

Dermagesic Cream (Dermagesic)

Dermagesic Cream (Dermagesic)

* Please review the disclaimer below.