Dynashield Cream
FDA Label NDC 67777-407

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dynarex Corporation for the product Dynashield (NDC 67777-407). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, purpose:, warnings:, when using this product:, stop use and ask a doctor if:, keep out of reach of children., dosage and administration:, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 (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.jpg

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