Petrolatum
FDA Label NDC 30400-211

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Jell Pharmaceuticals Pvt. Ltd. for the product Petrolatum (NDC 30400-211). 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, purpose:, warnings:, when using this product:, stop use and ask a doctor if:, indications & usage, keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient                            Purpose

White Petrolatum 100%                 Skin Protectant            

Purpose:

  • Helps treat and prevent diaper rash
  • Helps seal out wetness
  • Temporarily protects minor * cuts * scrapes * burns
  • Temporarily helps protect and helps relieve chapped and cracked skin and lips
  • Helps prevent and protect from the drying effects of wind and cold weather
  • Helps prevent and protect chaffed skin or minor skin irritations associated with diaper rash
  • With each diaper change, especially at bed time when exposure to wet diapers may be prolonged.

Warnings:

For external use only.

When Using This Product:

Do not get in eyes.

Stop Use And Ask A Doctor If:

  • Condition worsens
  • symptoms last more than 7 days or clear up and occur in a few days.

Indications & Usage

Do not use on:

  • Deep or puncture wounds
  • animal bites
  • serious burns

Keep Out Of Reach Of Children

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

Dosage & Administration

  • Change wet and soiled diapers promptly
  • cleanse the diaper area and allow to dry
  • apply as needed

Other Information:

  • Store at room temperature 15 Deg C - 30 Deg C (59 Deg F - 86 Deg F)
  • Avoid excessive heat 

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