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  5. Label Information: Barrier Protectant Cream

FDA Label for Barrier Protectant Cream

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. BARRIER PROTECTANT CREAM LABELING

Barrier Protectant Cream Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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