FDA.reportPublic FDA data

Essity (as PLD) - TENA PROSKIN BARRIER CREAM (59608-006)

Manufacturer
Essity HMS North America Inc
Effective date
2025-12-21
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:27:40

Label at a glance#

ProductTENA PROSKIN BARRIER
Active ingredientDIMETHICONE
Label structure10 sections

Indications and uses

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

Dosage and administration

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

Storage and handling

Store between 32°F and 85°F

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 5%

PURPOSE

OTC - PURPOSE SECTION

Skin Protectant

USES

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

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. 

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Store between 32°F and 85°F

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Tena_Barrier Cream_100mL01b LBL_Tena_Barrier Cream_100mL

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59608-006-01TENA PROSKIN BARRIER100 mL in 1 TUBECREAM1009

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59608-00659608-006-01

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
WATER059QF0KO0RIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
GLYCERINPDC6A3C0OXIACT
PEG-8 BEESWAX3C1QUF1TIRIACT
CETYL ALCOHOL936JST6JCNIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
SODIUM CITRATE1Q73Q2JULRIACT
CETETH-20I835H2IHHXIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SORBITAN MONOCAPRYLATE1VTA8DCP5QIACT
SODIUM BENZOATEOJ245FE5EUIACT
STEARETH-20L0Q8IK9E08IACT
HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 40-44)AS2SZ9757NIACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM GLUCONATER6Q3791S76IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
XANTHAN GUMTTV12P4NEEIACT
ACACIA DECURRENS FLOWER WAXAU6XZE9IY9IACT
POLYGLYCERIN-34A0NCJ6RD6IACT
TOCOPHEROLR0ZB2556P8IACT
DIMETHICONE92RU3N3Y1OACTIB

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
TENA PROSKIN BARRIERDIMETHICONEEssity HMS North America Inc118bf2df-ee7b-454f-9c0b-2697dc8262682025-12-21WarningsExact identifier
ndc (package): 59608-006-01
ndc (product): 59608-006
ndc11 (package): 59608000601
spl id: 467a1ea7-0abf-bd8a-e063-6394a90ae073
spl set id: 118bf2df-ee7b-454f-9c0b-2697dc826268

Reported adverse events (FAERS/openFDA)#

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