Dyna1199 With Dimethicone
FDA Label NDC 61767-228

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Blossom Pharmaceuticals for the product Dyna1199 With Dimethicone (NDC 61767-228). 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 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 150 - 300 C (590 - 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

DynaShield Skin Protectant

DynaDi1199.jpg

Dyna1199 With Dimethicone (Dynadi1199)

Dyna1199 With Dimethicone (Dynadi1199)

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