Zinc Oxide
FDA Label NDC 61767-222

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Blossom Pharmaceuticals for the product Zinc Oxide (NDC 61767-222). 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 active ingredient, purpose:, warnings:, when using this product:, stop use and ask a doctor if:, indications & usage:, keep out of reach of children, dosage & administration:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Indications & Usage:

  • 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.

Dosage & Administration:

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

Blossom Pharmaceuticals Zinc Oxide

zinc oxide.jpg

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