Diaper Rash Balm
FDA Label NDC 61328-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Skinfix, Inc. for the product Diaper Rash Balm (NDC 61328-001). 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 package label principal display, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Package Label Principal Display

Treats rash, redness & Irritation

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

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 balm liberally as often as necessary, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Image Components (Photo)

Image Components (Photo)

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