TENA

Manufacturer
SCA Personal Care Inc.
Effective date
2017-07-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:52:00

Label at a glance#

ProductTENA
Active ingredientZINC OXIDE
Label structure9 sections

Storage and handling

Other information Store between 32° F and 85° F

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Zinc Oxide 10%

OTC - PURPOSE SECTION

Purpose

Skin Protectant

INDICATIONS & USAGE SECTION

Uses

•helps treat and prevent skin rashes due to incontinence

•protects chafed skin due to incontinence and helps seal out wetness

WARNINGS SECTION

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 SECTION

Keep out of reach of children.  If swallowed, get medical help or contact a

Poison Control Center immediately

DOSAGE & ADMINISTRATION SECTION

Directions

•cleanse skin with TENA® Cleansing Cream and/or TENA® Washcloths

•apply cream sparingly and reapply as needed

STORAGE AND HANDLING SECTION

Other information Store between 32° F and 85° F

INACTIVE INGREDIENT SECTION

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

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1925201zinc oxide 10 % Topical LotionPSN3
1925201zinc oxide 100 MG/ML Topical LotionSCD3
1925201zinc oxide 10 % Topical LotionSY3
1925201ZNO 100 MG/ML Topical LotionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59608-003-052020-01-31C16284748780-19d75b9d0-5ffb-f424-e053-dadaa90a57cefe115e44-e97d-4cbc-8ec8-ebcae7f9e3f3
59608-003-102020-01-31C16284748780-19d75b9d0-5ffb-f424-e053-dadaa90a57cefe115e44-e97d-4cbc-8ec8-ebcae7f9e3f3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59608-003-05TENA5 mL in 1 TUBELOTION53
59608-003-10TENA100 mL in 1 TUBELOTION1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59608-003TENA (ZINC OXIDE PROTECTIVE CREAM) LOTION [SCA PERSONAL CARE INC.]3Legacy NDC, 2 package rows20170719_fe115e44-e97d-4cbc-8ec8-ebcae7f9e3f3.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59608-00359608-003-10, 59608-003-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4cae6538-9bea-4bdd-8ba6-d4b1b5029791fe115e44-e97d-4cbc-8ec8-ebcae7f9e3f32017-07-18WarningsExact identifier
spl id: 4cae6538-9bea-4bdd-8ba6-d4b1b5029791
spl set id: fe115e44-e97d-4cbc-8ec8-ebcae7f9e3f3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.