Selan Plus Zinc Oxide Cream
FDA Label NDC 0159-2200

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Trividia Manufacturing Solutions, Inc for the product Selan Plus Zinc Oxide (NDC 0159-2200). 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 ingredients, 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 Ingredients

Dimethicone 2.1%

Zinc Oxide 2%

Purpose

Skin Protectant

Uses

  • Helps treat and prevent diaper rash
  • Protects chaged skin or minor skin irritation due to diaper rash and helps seal out wetness

Warnings

For external use only

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

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

Other Information:

Store at room temperature

* Please review the disclaimer below.