Otc - Active Ingredient
Active Ingredient
Dimethicone 1%
Tena
FDA Label NDC 59608-002
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 59608-002). 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
•temporarily protects and helps prevent and relieve chafed, chapped, or cracked skin
•moisturizes and nourishes normal to dry skin to keep the skin feeling smooth and soft
Warnings
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.
Dosage & Administration
Directions
•apply as needed
Storage And Handling
Other information Store between 32° F and 85° F
Inactive Ingredient
Inactive Ingredients: Water, Dicaprylyl Carbonate, Glycerin, PEG-8
Beeswax, Cetyl Alcohol, Glyceryl Stearate SE, Caprylic/Capric Triglyceride, Sodium
Citrate, Ceteth-20, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sorbitan
Caprylate, Phenoxyethanol, Jojoba Esters, Sodium Benzoate, Steareth-20,
Helianthus Annus (Sunflower) Seed Wax, Citric Acid, Ethylhexylglycerin, Sodium
Gluconate, Xantham Gum, Acacia Decurrens Flower Wax, Polyglycerin-3, Tocopherol
Otc - Questions
Questions or comments?
Call 1-800-992-9939 or visit www.tena.us
Package Label.Principal Display Panel
Image Description (Sca 100)
Image Description (Sca 250)
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