Zinc Oxide Ointment
FDA Label NDC 67777-223

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 67777-223). 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, use(s), warnings, when using this product, stop use and ask a doctor if, 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

→ Active Ingredient

→ Purpose

→ Use(s)

→ Warnings

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Label

Active Ingredient

Zinc Oxide 20%

Purpose

Skin Protectant

Use(S)

• Helps treat chafed skin associated with diaper rash

• Dries the oozing and weeping of poison ivy, oak, and sumac

Warnings

For External Use Only

When Using This Product

• Avoid contact with eyes.

Stop Use And Ask A Doctor If

• Condition worsens • Symptoms last more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• For diaper rash: Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply ointment liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

• For poison ivy, oak, and sumac: Apply as needed.