Barrier Protectant Cream Ointment
FDA Label NDC 63517-003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health for the product Barrier Protectant Cream (NDC 63517-003). 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 ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

  • Menthol 0.1%
  • Zinc oxide 20%

Purpose

  • Anorectal analgesic
  • Skin protectant

Uses

A moisture barrier that provides temporary relief from skin irritations caused by   •urine   •diarrhea   •perspiration   •fistula drainage   •feeding tube site leakage   •wound drainage (peri-wound skin)   •minor burns   •cuts   •scrapes   •anorectal itching   •chafing

Dries the oozing and weeping of poison   •ivy   •oak   •sumac

Warnings

For external use only.

  • Avoid contact with the eyes
  • Stop use and contact a physician if condition worsens, symptoms last 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 Poison Control Center right away.

    • Do not use:

    • On deep or puncture wounds
    • Animal bites
    • Serious burns

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

  • Gently cleanse and remove any urine or fecal matter from the treatment area
  • Pat dry
  • Apply a generous amount of product to the affected area
  • Repeat after every incontinent episode or as needed
  • For peri-G tubes: •Cleanse as above  •Apply thin layer  •Secure with drain sponge or product as directed.

Other Information

Store between 59°-86°F (15°-30°C)

Inactive Ingredients

Active aloe gel, Calamine, Chamomilla recutita (matricaria) flower extract, Cod liver oil, Disodium EDTA, Glycerin, Lanolin, Light mineral oil, Manuka honey, Methylparaben, Microcrystalline wax, Petrolatum, Propylparaben, Sodium borate, Sorbitan oleate, Tocopherol, Water

Barrier Protectant Cream Labeling

Tube Label (2 oz)

Tube Label (4 oz)

Packet Labels (Box of 150)

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