FDA Label for Zinc Oxide

View Indications, Usage & Precautions

Zinc Oxide 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 (1.8% w/w)      Skin Protectant


Purpose:



  • Helps treat and prevent diaper rash
  • Temporarily protects
  • minor cuts
  • scrapes and
  • burns
  • 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

Keep Out Of Reach Of Children.



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


Dosage And Administration:



           For skin protectant:

  • Apply liberally as needed
  •            For diaper Rash:

    • change wet and soiled diapers promptly
    • allow to dry
    • apply ointment liberally with each diaper change

Other Information:



  • Store at room temperature
  • avoid excessive heat
  • contains color additives including FDC yellow # 5

Indications & Usage



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


Inactive Ingredient



Inactive ingredients:

Aloe Vera Leaf, Alpha-Tocopherol, Ceteth-10, Cetostearyl Alcohol, Cetyl Alcohol, Cholecalciferol, Glycerin, Lanolin, Lavender, Methylparaben, Mineral Oil, Paraffin, Petrolatum, Phenoxyethanol, Polyethylene Glycol 6000, Polysorbate 60, Propylparaben Sodium, Steareth-20, Trolamine, Vitamin A, Water



Principal Display Panel



Dynarex DynaShield Skin Protectant

zinc_oxide.jpg


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