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  5. Label Information: Dynarex Burn Cream

FDA Label for Dynarex Burn Cream

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. KEEP OUT OF REACH OF CHILDREN
    6. STOP USE
    7. DO NOT USE
    8. DIRECTIONS
    9. INACTIVE INGREDIENTS
    10. OTHER INFORMATION
    11. PRINCIPAL DISPLAY PANEL

Dynarex Burn Cream Product Label

The following document was submitted to the FDA by the labeler of this product Dynarex Corporation. 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



Active Ingredient                                       Purpose

Lidocaine HCL 0.5%                                   Topical Analgesic

Benzalkonium Chloride 0.13%                    Topical Antiseptic


Purpose



Temporary relief of pain and itching.


Uses



For temporary relief of pain and itching associated with:

  • Sunburn
  • Minor burns,
  • Insect bites,
  • Minor skin irritation,
  • Cuts and 
  • Scrapes

Warnings



FOR EXTERNAL USE ONLY


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.


Stop Use



Stop Use and ask a doctor:

  • If condition worsens or,
  • if symptoms persist for more than 7 days or clear up and occur again in a few days.
  • If pregnant or breast feeding, ask a health professional before use.


Do Not Use



Do Not Use:

  • In the eyes
  • Over large areas of the body or on deep puncture wounds, animal bites or serious burns.
  • In large quantities, particularly over raw surfaces or blistered areas.

Directions



Adults and children 2 years and over:

  • clean the affected area
  • apply a small amount of this product on the area 3 or 4 times daily.
  • may be covered with a sterile bandage

    • Children under 2 years

    • consult a doctor

Inactive Ingredients



Buttylated hydroxy toluene, Cetomacrogol, Cetostearyl alcohol, Dimethicone, Glycerine, Glyceryl monostearate, Isopropyl myristate, Methylcellulose, Purified water, Sodium EDTA, Sodium methylparaben, Sodium propylparaben


Other Information



Other Information

  • store in a cool, dry area
  • 59o to 79o F (15o to 25o C)
  • Tamper evident sealed packets do not use any open or torn packets

Principal Display Panel



Dynarex Burn Cream 

DFAC.jpg

Burn Cream - DFAC

Burn Cream - DFAC


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