Zinc Oxide
FDA Label NDC 67777-222

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 Zinc Oxide (NDC 67777-222). 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:, do not use on:, keep out of reach of children, directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Section Text

Active Ingredient                            Purpose

Zinc Oxide (200mg in each gram)   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:

  • conditions 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

Do Not Use On:

  • deep or puncture wounds
  • animal bites
  • serious burns

Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

For diaper rash:

  • change wet and soiled diapers promptly
  • cleanse 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

    • For poison ivy, poison oak, poison sumac:

    • apply liberally as often as needed

Inactive Ingredients

Cetostearyl alcohol, Cetomacrogal 1000, Light Liquid Paraffin, White Soft Paraffin

Principal Display

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Zinc Oxide (Zinc)

Zinc Oxide (Zinc)

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