Baby Bum Diaper Rash
FDA Label NDC 69039-638

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sun Bum Llc for the product Baby Bum Diaper Rash (NDC 69039-638). 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 drug facts, active ingredients, purpose, uses, warnings, when using this product, stop use and ask a doctor if, 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

Drug Facts

Active Ingredients

Zinc oxide 16%

Purpose

Skin protectant

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

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 withing a few 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 area to dry
  • apply cream liberally as often as necessary with each diaper change, especially at bedtime or any time exposure to wet diapers may be prolonged

Other Information

  • store between 20° to 25°C (68° to 77°F)
  • do not use if quality seal is broken

Inactive Ingredients

ricinus communis (castor) seed oil, hydrogenated castor oil, cocos nucifera (coconut) oil, beeswax, butyrospermum parkii (shea) butter, simmondsia chinensis (jojoba) seed oil, theobroma cacao (cocoa) seed butter, persea gratissima (avocado) oil, aloe barbadensis leaf extract, gardenia taitensis flower extract, tocopherol, hydrogenated vegetable oil

Questions?

1-877-978-6286

Package Labeling:

Label2 (Label2)

Label2 (Label2)

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