Dermagesic Liquid
FDA Label NDC 54859-120

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 Pharmaceuticals International Division for the product Dermagesic (NDC 54859-120). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients                   Purpose

Pramozine HCl .... 1% ............ Anesthetic/Analgesic

Zinc Oxide .........0.4% ............ Skin Protectant

Calamine ...........0.4% ............ Skin Protectant

Otc - Purpose

Purpose

Anesthetic/Analgesic

Skin Protectant

Indications & Usage

Uses

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

Warnings

Warnings

  • For external use only. Avoid contact with the eyes
  • Not for Pediatric use
  • Hypersensitivity to "caine" anesthetics
     

Otc - Do Not Use

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

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  SHAKE WELL

  • 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 Ingredient

Inactive Ingredients: Glycerin, glyceryl stearate, PEG-100 Stearate, cetearyl alcohol, methylparaben, propylparaben, aloe barbadensis leaf juic (aloe vera), avena sativa (oat) kernel colloidal oatmeal, fregrance, hydroxypropyl methylcellulose, menthol, purified water 

Otc - Questions

Questions:  1-866-595-5598

Package Label.Principal Display Panel

Dermagesiclabel (Newdermagesiclabel)

Dermagesiclabel (Newdermagesiclabel)

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