FDA.reportPublic FDA data

Essity (as PLD) - TENA PROSKIN BODY LOTION (59608-009)

Manufacturer
ESSITY HMS NORTH AMERICA INC
Effective date
2022-02-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:09:55

Label at a glance#

ProductTENA PROSKIN FRAGRANCE-FREE BODY
Active ingredientDIMETHICONE
Label structure10 sections

Indications and uses

TEMPORARILY PROTECTS AND HELPS PREVENT AND RELIEVE CHAFED, CHAPPED, OR CRACKED SKIN.

Dosage and administration

APPLY AS NEEDED.

Storage and handling

STORE BETWEEN 32°F AND 85°F

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

DIMETHICONE 1.1%

PURPOSE

OTC - PURPOSE SECTION

SKIN PROTECTANT

USES

INDICATIONS & USAGE SECTION

  • TEMPORARILY PROTECTS AND HELPS PREVENT AND RELIEVE 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 AGAINWITHIN 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

  • APPLY AS NEEDED.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

STORE BETWEEN 32°F AND 85°F

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER, DICAPRYLYL CARBONATE, PEG-8 BEESWAX, CETYL ALCOHOL, GLYCERYL STEARATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, SODIUM CITRATE, CETETH-20, ACRYLATES C10-30 ALKYL ACRYLATE CROSSPOLYMER, SODIUM CAPRYLATE, PHENOXYETHANOL, JOJOBA ESTERS, SODIUM BENZOATE, STEARETH-20, HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX, CITRIC ACID, ETHYLHEXYLGLYCERIN, SODIUM GLUCONATE, XANTHAN GUM, ACACIA DECURRENS FLOWER WAX, POLYGLYCERIN-3, TOCOPHEROL

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

CALL 1-866-275-8362 OR VISIT WWW.TENA.US

TENA CONSUMER CARE CENTER

P.O. BOX 8091

EAU CLAIRE, WI 54702-8091

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABELLABEL

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
59608-00959608-009-01

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
ACACIA DECURRENS FLOWER WAXAU6XZE9IY9IACT
POLYGLYCERIN-34A0NCJ6RD6IACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
SORBITAN MONOCAPRYLATE1VTA8DCP5QIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM CITRATE1Q73Q2JULRIACT
CETETH-20I835H2IHHXIACT
SODIUM BENZOATEOJ245FE5EUIACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
GLYCERINPDC6A3C0OXIACT
PEG-8 BEESWAX3C1QUF1TIRIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
STEARETH-20L0Q8IK9E08IACT
CETYL ALCOHOL936JST6JCNIACT
XANTHAN GUMTTV12P4NEEIACT
HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 40-44)AS2SZ9757NIACT
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM GLUCONATER6Q3791S76IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
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
d6fa3422-beaf-0772-e053-2995a90a4920d60ee279-1a76-7448-e053-2995a90a6de12022-02-01WarningsExact identifier
spl id: d6fa3422-beaf-0772-e053-2995a90a4920
spl set id: d60ee279-1a76-7448-e053-2995a90a6de1

Reported adverse events (FAERS/openFDA)#

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