Diaper Rash Skin Protectant Ointment
FDA Label NDC 52000-073

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Universal Distribution Centre Llc for the product Diaper Rash Skin Protectant (NDC 52000-073). 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 other, otc - purpose, uses, warnings, when using this product, stop use and ask a doctor if, do not use on, otc - 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

Otc - Purpose

Active ingredientsPurpose
Lanolin 15.5%Diaper rash ointment
Petrolatum 53.4%Skin Protectant

Uses

  • helps treat and prevent diaper rash
  • temporarily protects minor:
    • cuts
    • scrapes
    • burns
    • temporarily protects and helps relieve chapped, chafed or cracked skin and lips
    • protect chafed skin due to diaper rash and 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 again within a few days

Do Not Use On

  • deep or puncture wounds
  • animal bites
  • serious burns

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

  • for skin protectant useapply as needed
  • for diaper rash use:
    • 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 between 20°C to 25 °C (68° to 77°F)

Inactive Ingredients

cod liver oil ( contains vitamin A & vitamin D), fragrance, light mineral oil, microcrystalline wax, paraffin

* Please review the disclaimer below.