TENA- dimethicone moisturizing lotion cream

TENA by

Drug Labeling and Warnings

TENA by is a Otc medication manufactured, distributed, or labeled by SCA Personal Care Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Dimethicone 1%

PURPOSE

Purpose

Skin Protectant

INDICATIONS & USAGE

Uses

temporarily protects and helps prevent and relieve chafed, chapped, or cracked skin

moisturizes and nourishes normal to dry skin to keep the skin feeling smooth and soft

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

apply as needed

STORAGE AND HANDLING

Other information   Store between 32°  F and 85°  F

INACTIVE INGREDIENT

Inactive Ingredients:  Water, Dicaprylyl Carbonate, Glycerin, PEG-8

Beeswax, Cetyl Alcohol, Glyceryl Stearate SE, Caprylic/Capric Triglyceride, Sodium

Citrate, Ceteth-20, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sorbitan

Caprylate, Phenoxyethanol, Jojoba Esters, Sodium Benzoate, Steareth-20,

Helianthus Annus (Sunflower) Seed Wax, Citric Acid, Ethylhexylglycerin, Sodium

Gluconate, Xantham Gum, Acacia Decurrens Flower Wax, Polyglycerin-3, Tocopherol

QUESTIONS

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TENA 
dimethicone moisturizing lotion cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59608-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	.01 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
GLYCERIN (UNII: PDC6A3C0OX)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CETETH-20 (UNII: I835H2IHHX)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
SORBITAN (UNII: 6O92ICV9RU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARETH-20 (UNII: L0Q8IK9E08)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM GLUCONATE (UNII: R6Q3791S76)
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: 59608-002-10	100 mL in 1 TUBE; Type 0: Not a Combination Product	05/28/2017
2	NDC: 59608-002-25	250 mL in 1 TUBE; Type 0: Not a Combination Product	05/28/2017
3	NDC: 59608-002-05	5 mL in 1 TUBE; Type 0: Not a Combination Product	05/28/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/28/2017

Labeler - SCA Personal Care Inc. (790100549)