Procure Ointment
FDA Label NDC 55681-211

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Twin Med, Llc for the product Procure (NDC 55681-211). 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 active ingredient (in each gram), purpose, uses, directions, warnings, do not use on, 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

Active Ingredient (In Each Gram)

White Petrolatum, USP, 100% w/w

Purpose

Skin Protectant

Uses

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

Directions

  • Change wet and soiled diapers promptly
  • Cleanse the diaper area and allow to dry
  • Apply as needed

Warnings

For External Use Only.

Do Not Use On

  • Deep or puncture wounds
  • Animal bites
  • Serious burns

Stop Use And Ask A Doctor If

  • The condition persists or gets worse
  • Symptoms persists for more than 7 days or clear up and occur again within a few days.

Keep Out Of Reach Of Children

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

Other Information

  • Store at controlled room temperature 15o - 30oC(59o--86o F)
  • Avoid excessive heat and humidity
  • Tamper evident
  • Do not use if packet is torn, cut or opened

When Using This Product

  • Do not get into eyes

Principal Display Panel

ProCurePETROLATUMJELLYSkin Protectant144PACKETSNet Weight: 5 gramsItem No. PCPJO5

* Please review the disclaimer below.