Truelipids Boo-boo And Bum Balm Ointment
FDA Label NDC 61387-253

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Claridei Laboratories, Inc. for the product Truelipids Boo-boo And Bum Balm (NDC 61387-253). 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, warnings, dosage & administration, 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 Ingredient Purpose

White Petrolatum 50% Skin Protectant

Otc - Purpose

Uses

  • temporarily protects minor:
  • cuts
  • scrapes
  • burns
  • helps relieve, prevent and temporarily protect chafed, chapped or chracked skin.
  • helps treat and prevent diaper rash
  • protects minor skin irritation due to diaper rash and helps seal out wetness

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

Stop use and ask a doctor if
condition worsens
symptoms last more than 7 days or clear up and occur again within a few days

Warnings

Warnings

For external use only

When using this product:

  • do not get into eyes

    • Do not use on:

    • deep or puncture wounds
    • animal bites
    • serious burns

Dosage & Administration

Directions

  • ​For cuts, scrapes or burns.​
  • apply as needed
  • ​For diaper rash
  • change wet and soiled diapers promptly
  • ​cleanse the diaper area and allow to dry
  • pply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Inactive Ingredient

Inactive Ingredients:

Carpylic/Capric Triglyceride, Coco-Caprlyate, Microcrystalline Wax, Paraffin, Euphorbia Cerifera (Candililla) Wax, C10-C30 Cholesterol/Lanosterol Esters, Isostearyl Isostearate, Glycyrrhetinic Acid(Licorice Root), Phytosphingosine, Ceramide NP, Tocopherol

Package Label.Principal Display Panel

True Lipids Boo- Boo & Bum Balm

Net. Wt. 1.7 oz 50 g

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