FDA.reportPublic FDA data

TENA PROSKIN PROTECTIVE CREAM

Manufacturer
Essity HMS North America Inc.
Effective date
2021-07-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:41:04

Label at a glance#

ProductTENA PROSKIN PROTECTIVE
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

Helps treat and prevent diaper rash Temporarily protects chafed skin due to diaper rash and helps seal out wetness

Dosage and administration

cleanse skin with TENA ProSkin™ Cleansing Cream and/or TENA ProSkin™ Wipes apply as needed.

Storage and handling

Store between 32°F and 85°F

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

ZINC OXIDE 10%

PURPOSE

OTC - PURPOSE SECTION

SKIN PROTECTANT

USES

INDICATIONS & USAGE SECTION

  • Helps treat and prevent diaper rash
  • Temporarily protects chafed skin due to diaper rash and helps seal out wetness

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

  • 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.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • cleanse skin with TENA ProSkin™ Cleansing Cream and/or TENA ProSkin™ Wipes
  • apply as needed.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Store between 32°F and 85°F

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Dicaprylyl Carbonate, Caprylic/Capric Triglyceride, Glycerin, Magnesium Sulfate, Polyglyceryl-6 Polyhydroxystearate, Polyglyceryl-6 Polyricinoleate, Octyldodecanol, Phenoxyethanol, Sorbitan Olivate, Sodium Citrate, Sodium Benzoate, Jojoba Esters, Potassium Sorbate, Helianthus Annuus (Sunflower) Seed Wax, Disteardimonium Hectorite, Sodium Gluconate, Propylene Carbonate, Citric Acid, Acacia Decurrens Flower Wax, Polyglycerin-3, Tocopherol, Ascorbyl Palmitate.

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0-LBL_Tena ProSkin Protectant_100mL_US0-LBL_Tena ProSkin Protectant_100mL_US

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
59608-00759608-007-01

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
ASCORBYL PALMITATEQN83US2B0NIACT
POLYGLYCERIN-34A0NCJ6RD6IACT
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERINPDC6A3C0OXIACT
MAGNESIUM SULFATE ANHYDROUSML30MJ2U7IIACT
POLYGLYCERYL-6 POLYRICINOLEATEYPM0ZOC2HRIACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
OCTYLDODECANOL461N1O614YIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SORBITAN OLIVATEMDL271E3GRIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SODIUM BENZOATEOJ245FE5EUIACT
HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 64-70)96YYQ5TK1KIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
SODIUM GLUCONATER6Q3791S76IACT
PROPYLENE CARBONATE8D08K3S51EIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
ACACIA DECURRENS FLOWER WAXAU6XZE9IY9IACT
ZINC OXIDESOI2LOH54ZACTIB

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
d66f5d2d-15df-0c55-e053-2a95a90aa4abc6bab358-c7d9-62d6-e053-2a95a90a339b2022-01-25WarningsExact identifier
spl set id: c6bab358-c7d9-62d6-e053-2a95a90a339b

Reported adverse events (FAERS/openFDA)#

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