Baby Petroleum Jelly Cream
FDA Label NDC 57337-076

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rejoice International Inc. for the product Baby Petroleum Jelly (NDC 57337-076). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, dosage & administration, warnings, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients                      Purpose

White Petroleum 99.9% ...... skin protectant

Otc - Purpose

Uses

temporarily protects and helps relieve chapped or cracked skin and lips

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.

Indications & Usage

XtraCare

100% Pure Petroleum Jelly

Baby Fresh Scent

Dosage & Administration

Directions

  • change and cleanse diaper area, and allow to dry
  • apply product as needed, with each diaper change, especially at bedtime and when exposure to wet diapers may be prolonged

Warnings

Warnings

For external use only

When using this product do not get into eyes

See a doctor if condition lasts more than 7 days

Do not use on

  • deep puncture wounds
  • animal bites
  • serious burns

Inactive Ingredient

Inactive ingredients fragrance

Package Label.Principal Display Panel

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