Diaper Rash
FDA Label NDC 59970-045

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Navarro Discount Pharmacies,llc for the product Diaper Rash (NDC 59970-045). 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, do not use, 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.

Active Ingredient

Zinc Oxide 40%

Purpose

Skin Protectant

Uses

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps protect skin from wetness
  • helps prevent and temporarily protect chafed, chapped, cracked or windburned skin lips

Warnings

For external use only

Do Not Use

over deep or puncture wounds, infections or lacerations

When Using This Product

avoid contact with the eyes

Stop Use And Ask A Doctor

if condition worsens or does not improve within 7 days.

Keep Out Of Reach Of Children.

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

Directions

  • cleanse the diaper area
  • 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

Other Information

  • store at room temperature

Inactive Ingredients

Talc, Vacellin, Bees wax, Dimethicone, Liquid paraffin, Tocopherol acetate, Sesquioleate sorbitan, Aloe vera gel, Methylparaben, Propylparaben, Purified water

Package Label

Vida Mia Diaper Rash Cream

Image Of Product Carton (Nav.diaper.carton)

Image Of Product Carton (Nav.diaper.carton)

* Please review the disclaimer below.