Leader Zinc Oxide Ointment
FDA Label NDC 70000-0334

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110,inc. for the product Leader Zinc Oxide (NDC 70000-0334). 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 drug facts, purpose, uses, warnings, otc - when using, otc - stop use, otc - 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

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
  • symptoms last more than 7 days to clear up and occur again within a few 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

      • For Poison Ivy, poison oak and poison sumac;

      • cleanse the affect area and pat dry 
      • apply ointment liberally, as often as necessary, using a cotton ball, sterile swab or gauze
      • wash hands after use.

Inactive Ingredients

mineral oil, petrolatum

Questions Or Comments?

Call 1-800-222-1087

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

Principal Display Panel – Jar Label

Leader®       NDC 70000-0334-1

Zinc Oxide

Ointment USP•

Multi Purpose Skin Protectant 

provides soothing relief from poison ivy,

oak and sumac

Treats and prevents diaper rash

Net Wt 1 lb (454 g)

Principal Display Panel – Jar Label (Leader Zinc Lbl)

Principal Display Panel – Jar Label (Leader Zinc Lbl)


Principal Display Panel – Jar Label (Leader Zinc Lbl)

Principal Display Panel – Jar Label (Leader Zinc Lbl)

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