Qc Diaper Rash
FDA Label NDC 64525-5382

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Quality Home Products for the product Qc Diaper Rash (NDC 64525-5382). 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.

Label Section Quick Index

Active Ingredient

Zinc Oxide 10%

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

  • change wet and soiled diapers promptly, cleanse the diaper area, and 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
  • Lot No and Exp Date: see box or see crimp of tube

Inactive Ingredients

aloe vera gel, butylated hydroxytoluene, liquid paraffin, methyl parahydroxybenzoate, talc, tocopherol acetate, triethanolamine, purified lanolin, purified water, white petrolatum

Package Label

QC Diaper Rash Cream

Image Of Product Carton (Qcdiaper.carton)

Image Of Product Carton (Qcdiaper.carton)

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