FDA.reportPublic FDA data

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 ingredientDIMETHICONE
Label structure11 sections

Storage and handling

Other information    Store between 32°  F and 85°  F

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Dimethicone 1%

OTC - PURPOSE SECTION

Purpose

Skin Protectant

INDICATIONS & USAGE SECTION

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 SECTION

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 SECTION

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

Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

•apply as needed

STORAGE AND HANDLING SECTION

Other information   Store between 32°  F and 85°  F

INACTIVE INGREDIENT SECTION

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 SECTION

Questions or comments?

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - 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
59608-002-052020-01-31C16284748780-19d75b9cf-dc70-f424-e053-dadaa90a57ceDrug Facts
59608-002-102020-01-31C16284748780-19d75b9cf-dc70-f424-e053-dadaa90a57ceDrug Facts
59608-002-252020-01-31C16284748780-19d75b9cf-dc70-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59608-002-05TENA5 mL in 1 TUBECREAM53
59608-002-10TENA100 mL in 1 TUBECREAM1003
59608-002-25TENA250 mL in 1 TUBECREAM2503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59608-002TENA (DIMETHICONE MOISTURIZING LOTION) CREAM [SCA PERSONAL CARE INC.]3Legacy NDC, 3 package rows20170719_cef19bfb-64fc-4266-afae-5e94f30a3f70.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
59608-00259608-002-10, 59608-002-25, 59608-002-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
WATER059QF0KO0RIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
GLYCERINPDC6A3C0OXIACT
YELLOW WAX2ZA36H0S2VIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SODIUM CITRATE1Q73Q2JULRIACT
CETETH-20I835H2IHHXIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
SORBITAN6O92ICV9RUIACT
PHENOXYETHANOLHIE492ZZ3TIACT
JOJOBA OIL, RANDOMIZED7F0EV20QYLIACT
SODIUM BENZOATEOJ245FE5EUIACT
STEARETH-20L0Q8IK9E08IACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SODIUM GLUCONATER6Q3791S76IACT
XANTHAN GUMTTV12P4NEEIACT
ACACIA DECURRENS FLOWER WAXAU6XZE9IY9IACT
POLYGLYCERIN-34A0NCJ6RD6IACT
TOCOPHEROLR0ZB2556P8IACT

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
24c2a581-da2f-40fc-a806-f73820337681cef19bfb-64fc-4266-afae-5e94f30a3f702017-07-18WarningsExact identifier
spl id: 24c2a581-da2f-40fc-a806-f73820337681
spl set id: cef19bfb-64fc-4266-afae-5e94f30a3f70

Reported adverse events (FAERS/openFDA)#

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