FDA.reportPublic FDA data

TENA Protective Cream

Manufacturer
Essity HMS North America Inc
Effective date
2020-02-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 23:41:18

Label at a glance#

ProductTENA Protective Cream
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

helps treat and prevent minor skin irritation assoicated with incontinence protects and helps relieve chafed, chapped or cracked skin

Dosage and administration

gently cleanse skin as required apply cream sparingly to affected area and reapply as needed

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 minor skin irritation assoicated with incontinence
  • protects and helps relieve chafed, chapped or cracked skin

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • gently cleanse skin as required
  • apply cream sparingly to affected area and reapply as needed

Other information

OTHER SAFETY INFORMATION

  • store at a temperature between 32°Fand 85°F

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzoic acid, betaine, canola oil, caprylic/capric triglyceride, cera alba, dehydroacetic acid, ethylhexyl stearate, glycerin, glyceryl oleate, hydrogenated vegetable oil, magnesium stearate, magnesium sulfate, panthenol, phenoxyethanol, polyglyceryl-3 ricinoleate, tocopheryl acetate, water

 Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-992-9939 or visit www.tena-usa.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TENA Protective Cream

Irritated & sensitive skin

Scent Free

10% zinc oxide

Principal Display Panel -TubePrincipal Display Panel -Tube

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59608-001-012023-06-14C16284748780-19d75b9d0-d8ee-f424-e053-dadaa90a57ceTENA PROTECTIVE CREAM Scent Free, 100mL 59608-001
59608-001-022023-06-14C16284748780-19d75b9d0-d8ee-f424-e053-dadaa90a57ceTENA PROTECTIVE CREAM Scent Free, 100mL 59608-001
59608-001-032023-06-14C16284748780-19d75b9d0-d8ee-f424-e053-dadaa90a57ceTENA PROTECTIVE CREAM Scent Free, 100mL 59608-001
59608-001-042023-06-14C16284748780-19d75b9d0-d8ee-f424-e053-dadaa90a57ceTENA PROTECTIVE CREAM Scent Free, 100mL 59608-001
59608-001-012023-01-30C16284748780-19d75b9d0-d8ee-f424-e053-dadaa90a57ceTENA PROTECTIVE CREAM Scent Free, 100mL 59608-001
59608-001-022023-01-30C16284748780-19d75b9d0-d8ee-f424-e053-dadaa90a57ceTENA PROTECTIVE CREAM Scent Free, 100mL 59608-001
59608-001-032023-01-30C16284748780-19d75b9d0-d8ee-f424-e053-dadaa90a57ceTENA PROTECTIVE CREAM Scent Free, 100mL 59608-001
59608-001-042023-01-30C16284748780-19d75b9d0-d8ee-f424-e053-dadaa90a57ceTENA PROTECTIVE CREAM Scent Free, 100mL 59608-001
59608-001-012020-02-11C16284748780-19d75b9d0-d8ee-f424-e053-dadaa90a57ceTENA PROTECTIVE CREAM Scent Free, 100mL 59608-001
59608-001-022020-02-11C16284748780-19d75b9d0-d8ee-f424-e053-dadaa90a57ceTENA PROTECTIVE CREAM Scent Free, 100mL 59608-001
59608-001-032020-02-11C16284748780-19d75b9d0-d8ee-f424-e053-dadaa90a57ceTENA PROTECTIVE CREAM Scent Free, 100mL 59608-001
59608-001-042020-02-11C16284748780-19d75b9d0-d8ee-f424-e053-dadaa90a57ceTENA PROTECTIVE CREAM Scent Free, 100mL 59608-001
59608-001-012020-01-31C16284748780-19d75b9d0-d8ee-f424-e053-dadaa90a57ceTENA PROTECTIVE CREAM Scent Free, 100mL 59608-001
59608-001-022020-01-31C16284748780-19d75b9d0-d8ee-f424-e053-dadaa90a57ceTENA PROTECTIVE CREAM Scent Free, 100mL 59608-001
59608-001-032020-01-31C16284748780-19d75b9d0-d8ee-f424-e053-dadaa90a57ceTENA PROTECTIVE CREAM Scent Free, 100mL 59608-001
59608-001-042020-01-31C16284748780-19d75b9d0-d8ee-f424-e053-dadaa90a57ceTENA PROTECTIVE CREAM Scent Free, 100mL 59608-001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z2
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L02
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIM2
BETAINEINACTIVE INGREDIENT3SCV180C9W2
CANOLA OILINACTIVE INGREDIENT331KBJ17RK2
DEHYDROACETIC ACIDINACTIVE INGREDIENT2KAG279R6R2
ETHYLHEXYL STEARATEINACTIVE INGREDIENTEG3PA2K3K52
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
GLYCERYL OLEATEINACTIVE INGREDIENT4PC054V79P2
HYDROGENATED COCONUT OILINACTIVE INGREDIENTJY81OXM1OM2
HYDROGENATED RAPESEED OILINACTIVE INGREDIENTK168T6Y0YU2
HYDROGENATED SOYBEAN OILINACTIVE INGREDIENTA2M91M918C2
MAGNESIUM PALMITATEINACTIVE INGREDIENTJJ0UR696JR2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I302
MAGNESIUM SULFATEINACTIVE INGREDIENTDE08037SAB2
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
POLYGLYCERYL-3 RICINOLEATEINACTIVE INGREDIENTMZQ63P0N0W2
TRICAPRININACTIVE INGREDIENTO1PB8EU98M2
WATERINACTIVE INGREDIENT059QF0KO0R2
WHITE WAXINACTIVE INGREDIENT7G1J5DA97F2

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59608-00159608-001-02, 59608-001-01, 59608-001-04, 59608-001-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CANOLA OIL331KBJ17RKIACT
TRICAPRINO1PB8EU98MIACT
GLYCERINPDC6A3C0OXIACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
WHITE WAX7G1J5DA97FIACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
HYDROGENATED SOYBEAN OILA2M91M918CIACT
HYDROGENATED RAPESEED OILK168T6Y0YUIACT
HYDROGENATED COCONUT OILJY81OXM1OMIACT
BETAINE3SCV180C9WIACT
GLYCERYL OLEATE4PC054V79PIACT
PANTHENOLWV9CM0O67ZIACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
MAGNESIUM STEARATE70097M6I30IACT
MAGNESIUM PALMITATEJJ0UR696JRIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BENZOIC ACID8SKN0B0MIMIACT
DEHYDROACETIC ACID2KAG279R6RIACT
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 181 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMTABLET, FILM COATED / ORALNAExact identifier — unii candidate
23 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
MAGNESIUM SULFATEMAGNESIUM SULFATEDE08037SABTABLET, FILM COATED / ORAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FCREAM, AUGMENTED / TOPICAL10 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMLOTION / TOPICAL0.2 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / ORAL25 mgExact identifier — unii candidate
39 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, ORALLY DISINTEGRATING / ORAL187 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM SULFATEMAGNESIUM SULFATEDE08037SABSOAP / TOPICAL0.2 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERYL OLEATEGLYCERYL OLEATE4PC054V79PPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
7 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FTABLET, FILM COATED / ORAL0.2 mgExact identifier — unii candidate
15 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / RESPIRATORY (INHALATION)0.13 mgExact identifier — unii candidate
39 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSOLUTION / TOPICAL0.1 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERYL OLEATEGLYCERYL OLEATE4PC054V79PCREAM, AUGMENTED / TOPICAL3.5 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSUSPENSION / RECTAL0.1 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSUSPENSION / ORAL15 mgExact identifier — unii candidate
23 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30DROPS / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30IMPLANT / SUBCUTANEOUS0.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMTABLET, COATED / ORALNAExact identifier — unii candidate
23 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
HYDROGENATED COCONUT OILHYDROGENATED COCONUT OILJY81OXM1OMSUPPOSITORY / RECTALNAExact identifier — unii candidate
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FAEROSOL, FOAM / TOPICAL2 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMMOUTHWASH / BUCCALNAExact identifier — unii candidate
23 equally ranked IID candidates
GLYCERYL OLEATEGLYCERYL OLEATE4PC054V79PGEL / TOPICAL1 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FTABLET, EXTENDED RELEASE / ORAL14 mgExact identifier — unii candidate
15 equally ranked IID candidates
HYDROGENATED SOYBEAN OILHYDROGENATED SOYBEAN OILA2M91M918CTABLET / ORAL13.5 mgExact identifier — unii candidate
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30INSERT / VAGINAL69 mgExact identifier — unii candidate
39 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FCREAM / VAGINAL40 mgExact identifier — unii candidate
15 equally ranked IID candidates
MAGNESIUM SULFATEMAGNESIUM SULFATEDE08037SABTABLET / ORAL2.9 mgExact identifier — unii candidate
6 equally ranked IID candidates

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
fe101e58-b95a-14ec-e053-6294a90a61180fd86e4b-8ea4-4895-9b9d-ab2ba1d2eb302023-06-14WarningsExact identifier
spl set id: 0fd86e4b-8ea4-4895-9b9d-ab2ba1d2eb30

Reported adverse events (FAERS/openFDA)#

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