FDA Label for Dynashield With Dimethicone

View Indications, Usage & Precautions

Dynashield With Dimethicone 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.

Otc - Active Ingredient



Active Ingredient               Purpose

Zinc Oxide 2%                   Diaper Rash

Dimethicone 1.8%              Skin Protectant


Purpose:



  • Helps treat and prevent diaper rash
  • Dries the oozing and weeping of;
  • poison ivy
  • poison oak
  • poison sumac

Warnings:



For External Use Only.


When Using This Product:



Do not get in eyes.


Stop Use And Ask A Doctor If:



  • condition worsens
  • symptoms last more than 7 days or clear up and occur again in a few days, consult a physician
  • over large areas of the body
  • if you are allergic to any of these ingredients

Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


Dosage And Administration:



           For poison ivy, oak and sumac:

  • Apply ointment liberally as often as needed
  •            For diaper Rash:

    • change wet and soiled diapers promptly
    • clean the diaper area and allow to dry
    • apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Other Information:



  • Do not use if seal is punctured or not visible
  • Store at room temperature 15- 30C (59- 860 F)
  • avoid excessive heat
  • contains color additives including FDC yellow # 5 (Tartrazine)

Indications & Usage



Indications: For use as a general skin protectant and diaper rash.


Inactive Ingredient



Inactive ingredients:

Aloe Vera Leaf, Alpha-Tocopherol, Ceteth-20, Cetostearyl Alcohol, Cetyl Alcohol, Cholecalciferol, Glycerin, Lanolin, Lavender perfume, Methylparaben, Mineral Oil, Petrolatum, Propylparaben, Trolamine, Vitamin A, Water


Principal Display Panel



Dynarex DynaShield Skin Protectant

dynashield dimeth.jpg


* Please review the disclaimer below.