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

TENA PROSKIN BARRIER by

Drug Labeling and Warnings

TENA PROSKIN BARRIER by is a Otc medication manufactured, distributed, or labeled by Essity HMS North America Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TENA PROSKIN BARRIER- dimethicone cream 
Essity HMS North America Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

ACTIVE INGREDIENT

Dimethicone 5%

PURPOSE

Skin Protectant

USES

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

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. 

DIRECTIONS

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

OTHER INFORMATION

Store between 32°F and 85°F

INACTIVE INGREDIENTS

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?

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

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

01b LBL_Tena_Barrier Cream_100mL

TENA PROSKIN BARRIER 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59608-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-8 BEESWAX (UNII: 3C1QUF1TIR)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
CETETH-20 (UNII: I835H2IHHX)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SORBITAN MONOCAPRYLATE (UNII: 1VTA8DCP5Q)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARETH-20 (UNII: L0Q8IK9E08)  
HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 40-44) (UNII: AS2SZ9757N)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SODIUM GLUCONATE (UNII: R6Q3791S76)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 59608-006-01100 mL in 1 TUBE; Type 0: Not a Combination Product11/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/03/2020
Labeler - Essity HMS North America Inc (787850148)

Revised: 1/2022
Document Id: d66f65f3-e70a-4b55-e053-2a95a90a380b
Set id: 118bf2df-ee7b-454f-9c0b-2697dc826268
Version: 5
Effective Time: 20220125