TENA BARRIER CREAM- 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 Barrier Cream (59608-005)

Active Ingredient

Dimethicone 1.2%

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® Cleansing Cream and/or TENA®

Washcloths  •apply cream liberally and reapply as needed

Other Information  Store between 32°F and 85°F

Inactive Ingredients:  Acacia Decurrens

Flower Wax, Allantoin, Aloe Barbadensis Leaf Juice, Avena

Sativa (Oat) Kernel Flour, Behentrimonium Methosulfate,

Butylene Glycol, Calendula Officinalis Flower Oil, 

Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetyl Alcohol, 

Chamomilla Recutita (Matricaria) Flower Extract, Copernica

Cerifera (Carnauba) Wax, Distearyldimonium Chloride, 

Ethylhexylglycerin, Glycerin, Helianthus Annus (Sunflower)

Seed Wax, Hydrogenated Castor Oil, Isopropyl Palmitate, 

Jojoba Esters, Lactic Acid, Phenoxyethanol, Polyglycerin-3, 

Potassium Sorbate, Ricinus Communis (Castor) Seed Oil, 

Sodium Benzoate, Sodium Chloride, Sorbitan Caprylate, Water

Questions or comments? 

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

image description

image description

TENA BARRIER CREAM 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59608-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.012 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
OAT KERNEL OIL (UNII: 3UVP41R77R)  
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
MATRICARIA CHAMOMILLA LEAF (UNII: 6I9LN466F0)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
LACTIC ACID (UNII: 33X04XA5AT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CASTOR OIL (UNII: D5340Y2I9G)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SORBITAN MONOCAPRYLATE (UNII: 1VTA8DCP5Q)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59608-005-17100 mL in 1 TUBE; Type 0: Not a Combination Product07/29/201812/31/2022
2NDC:59608-005-345 mL in 1 BAG; Type 0: Not a Combination Product07/29/201812/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/29/201812/31/2022
Labeler - Essity HMS North America Inc (787850148)

Revised: 7/2023
 
Essity HMS North America Inc