Formula 21 Diaper Rash
FDA Label NDC 42416-0021

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dra Bello Products, Inc. for the product Formula 21 Diaper Rash (NDC 42416-0021). 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, when using this product, stop use and as 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 Ingredient

→ Purpose

→ Uses

→ Warnings

→ When Using This Product

→ Stop Use And As Doctor If

→ Keep Out Of Reach Of Children.

→ Directions

→ Inactive Ingredients

→ Product Label

Active Ingredient

Zinc Oxide 25%

Purpose

Skin Protectant

Uses

Helps treat and prevent diaper rash. Protects minor skin irritation due to diaper rash and helps protect from wetness.

Warnings

For external use only.

When Using This Product

Do not get in eyes.

Stop Use And As Doctor If

conditions worsen
symptoms last more than 7 days or clear up and return again within a few days

Keep Out Of Reach Of Children.

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

Directions

Change wet and soiled diapers promptly, cleanse the diaper area and allow to dry. Apply product liberally as often as necessary, with each diaper change especially at bedtime or any time when exposure to wet diapers may be prolonged.