Sheffield Zinc Oxide Ointment
FDA Label NDC 11527-065

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sheffield Pharmaceuticals Llc for the product Sheffield Zinc Oxide (NDC 11527-065). 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 other, active ingredient, purpose, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Zinc oxide 20%

Purpose

Skin Protectant

Uses

  • helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness.
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac.

Warnings

For external use only

Otc - When Using

When using this product, avoid contact with the eyes

Otc - Stop Use

Stop use and ask a doctor if condition worsens or does not improve within 7 days

Otc - 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

  • apply liberally as often as necessary

For Diaper Rash:

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

Inactive Ingredients

mineral oil, petrolatum

Questions Or Comments?

Call 1-800-222-1087

Store at room temperature 20° - 25°C (68° - 77°F).

Package Label.Principal Display Panel

Sheffield Pharmaceuticals -Tube label 


SKIN PROTECTANT

Zinc Oxide
Ointment USP
• provides soothing relief from poison ivy,
oak and sumac
• Treats and prevents diaper rash

NET WT 1 OZ (28g)

Sheffield Pharmaceuticals Zinc Oxide Ointment USP- Carton label 

Skin protectant 

Help Soothe & Protect Chafed Skin

NET WT 1 oz (28g)

* Please review the disclaimer below.