TENA BARRIER CREAM- dimethicone cream

TENA Barrier Cream by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Dimethicone 1.2%

PURPOSE

Purpose

Skin Protectant

INDICATIONS & USAGE

Uses

protects skin from irritation casued by contact with urine and/or

stool  helps prevent and releive chafed, chapped or cracked skin

WARNINGS

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

Keep out of reach of children. If swallowed, get medical

help or contact a Poison Control Center immediately. 

DOSAGE & ADMINISTRATION

Directions

cleanse skin with TENA® Cleansing Cream and/or TENA®

Washcloths  apply cream liberally and reapply as needed

STORAGE AND HANDLING

Other Information  Store between 32°F and 85°F

INACTIVE INGREDIENT

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

Questions or comments? 

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TENA BARRIER CREAM 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59608-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	.012 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59608-005-17	100 mL in 1 TUBE; Type 0: Not a Combination Product	07/29/2018
2	NDC: 59608-005-34	5 mL in 1 BAG; Type 0: Not a Combination Product	07/29/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/29/2018

Labeler - Essity HMS North America Inc (787850148)