Tena Proskin Barrier Cream
FDA Label NDC 59608-006

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Essity Hms North America Inc for the product Tena Proskin Barrier (NDC 59608-006). 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, 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 Ingredient

Dimethicone 5%

Purpose

Skin Protectant

Uses

  • protects skin from irritation casued by contact with urine and/or stool
  • helps prevent and releive chafed, chapped, or cracked skin

Warnings

For external use only.

Do not use

  • on deep or puncture wounds
  • on animal bites
  • on serious burns

    • When using this product

    • do not get into eyes

      • 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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. 

Directions

  • cleanse skin with TENA PROSKIN Cleansing Cream and/or TENA PROSKIN WIPES
  • apply cream liberally and reapply as needed

Other Information

Store between 32°F and 85°F

Inactive Ingredients

Water, Dicaprylyl Carbonate, Glycerin, PEG-8 Beeswax, Cetyl Alcohol, Caprylic/Capric Triglyceride, Glyceryl Stearate SE, Sodium Citrate,  Ceteth-20, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Sorbitan Caprylate, Sodium Benzoate, Steareth-20, Jojoba Esters, Helianthus Annuus (Sunflower) Seed Wax, Citric Acid, Sodium Gluconate, Ethylhexylglycerin, Xanthan Gum, Acacia Decurrens Flower Wax,
Polyglycerin-3, Tocopherol.

Questions Or Comments?

Call 1-800-992-9939 or visit www.tena.us

TENA® Consumer Care Center
P.O. Box 8091
Eau Claire, WI 54702-8091

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