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  5. Label Information: Dermagesic

FDA Label for Dermagesic

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. KEEP OUT OF REACH OF CHILDREN
    6. DIRECTIONS
    7. INACTIVE INGREDIENTS
    8. QUESTIONS OR COMMENTS
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dermagesic Product Label

The following document was submitted to the FDA by the labeler of this product Llorens Pharmaceutical International Division. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


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