Zinc Oxide
FDA Label NDC 36800-100

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Zinc Oxide (NDC 36800-100). 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, uses, 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

Zinc Oxide 20%

Purpose

Skin Protectant

Uses

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash
  • helps seal out wetness

Warnings

For external use only.

When Using This Product

  • do not get into eyes

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms last more than 7 days or clear up and occur within a few days.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • change wet or soiled diapers promptly
  • clean the diaper area
  • allow to dry
  • apply cream liberally as often as necessary, with each diaper change, especially at bedtime or any time prolonged exposure to wet diapers may be prolonged.

Other Information

  • store at 20-25°C (68-77°F)

Inactive Ingredients

bees wax, BHT, cod liver oil, fragrance, lanolin, methylparaben, petrolatum, purified water

Package Label.Principal Display Panel

Image Of Carton Label (Zincoxide)

Image Of Carton Label (Zincoxide)

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