Diaperderm Diaper Rash Cream
FDA Label NDC 80651-093

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Diaperderm Inc for the product Diaperderm Diaper Rash (NDC 80651-093). 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, active ingredient, purpose, uses:, warnings, when using this product,, stop use and ask a doctor, 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

Drug Facts

Active Ingredient

Zinc Oxide 5%

Purpose

Skin Protectant

Uses:

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

Warnings

For external use only.

When Using This Product,

avoid contact with eyes.

Stop Use And Ask A Doctor

if condition worsens or symptoms last more than 7 days.

Keep Out Of Reach Of Children.

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

Directions

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

Inactive Ingredients

lanolin, petrolatum, vitamin A, vitamin D3

Package Labeling:

Box (Box)

Box (Box)

* Please review the disclaimer below.