TENA PROSKIN BARRIER- dimethicone cream

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]

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TENA PROSKIN BARRIER 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59608-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59608-006-01	100 mL in 1 TUBE; Type 0: Not a Combination Product	11/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	11/03/2020

Labeler - Essity HMS North America Inc (787850148)