Repara
FDA Label NDC 68345-818

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pss World Medical, Inc. for the product Repara (NDC 68345-818). 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, dosage & administration, warnings, indications & usage, inactive ingredient, other safety information, 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

Lanolin USP 50% .................. Skin Protectant

Otc - Purpose

Repara Advanced Skincare

Skin Protectant w/ Lanolin

Multi-Purpose

  • Contains 50% Lanolin USP
  • Skin Barrier for Incontinence Diaper Rash
  • Protects chafed or ulcer prone skin

    • Light Scent

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.

Dosage & Administration

Directions

  • Gently cleanse and dry area.
  • Apply liberally to affected area as needed.

Warnings

Warnings

  • For external use only
  • When using this product
  • do not get into eyes.
  • Do not apply to deep or puncture wounds.
  • 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.

Indications & Usage

Indications: Intended to help protect chafed skin or minor skin irritations, as well as to prevent diaper dermatitis.

Precautions: FOR EXTERNAL USE ONLY. Discontinue use should irritation occur. Do not use on deep puncture wounds, animal bites, and serious burns.

Frequency: Daily.

Uses

  • Helps prevent diaper dermatitis.
  • Protects chafed skin or minor skin irritations due to incontinence and helps seal out wetness.

Inactive Ingredient

Inactive Ingredients

beeswax (yellow wax), fragrance, HEEDTA, lanolin alcohol, mineral oil, oxyquinolone, petrolatum, purified water, sodium borate, sorbitan sesquioleate.

Other Safety Information

Manufactured for PSS World Medical, Inc.

4345 Southpoint Blvd., Jacksonville, FL 32216

Comments or Questions? 800-777-4908

Made in the USA

Other Information

Store at 20oC - 25oC (68oF - 77oF).

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