Otc - Active Ingredient
Active Ingredient
Zinc Oxide 10%
Tena
FDA Label NDC 59608-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sca Personal Care Inc. for the product Tena (NDC 59608-003). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Skin Protectant
Indications & Usage
Uses
•helps treat and prevent skin rashes due to incontinence
•protects chafed skin due to incontinence and helps seal out wetness
Warnings
Warnings
For external use only.
Do not use •on deep or puncture wounds •on animal bites •on serious burns
When using this product •avoid contact with 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
Dosage & Administration
Directions
•cleanse skin with TENA® Cleansing Cream and/or TENA® Washcloths
•apply cream sparingly and reapply as needed
Storage And Handling
Other information Store between 32° F and 85° F
Inactive Ingredient
Inactive ingredients: Acacia Decurrens Flower Wax, Caprylic/Capric Triglyceride, Citric Acid, Dicaprylyl Carbonate,
Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Seed Wax, Jojoba Esters, Magnesium Sulfate, PEG-8 Beeswax, Polyglycerin-3,
Polyglyceryl-3 Ricinoleate, Potassium Sorbate, Sodium Benzoate, Sodium Citrate, Sodium Gluconate, Sorbitan Caprylate, Sorbitan
Isostearate, Tocopherol, Vegetable Oil, Water.
Package Label.Principal Display Panel
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