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 Gerimedix Incorporated. 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

Dosage & 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


Keep Out Of Reach Of Children.



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


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 Ingredients



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



Principle Display Panel



Geriguard Skin Protectant

Zinc Oxide Ointment

zinc_oxide.jpg


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