TENA- zinc oxide protective cream lotion

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

Zinc Oxide 10%

PURPOSE

Purpose

Skin Protectant

INDICATIONS & USAGE

Uses

helps treat and prevent skin rashes due to incontinence

protects chafed skin due to incontinence and helps seal out wetness

WARNINGS

Warnings

For external use only.

Do not use on deep or puncture wounds  on animal bites  on serious burns

When using this product  avoid contact with 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 sparingly and reapply as needed

STORAGE AND HANDLING

Other information Store between 32° F and 85° F

INACTIVE INGREDIENT

Inactive ingredients:  Acacia Decurrens Flower Wax, Caprylic/Capric Triglyceride, Citric Acid, Dicaprylyl Carbonate,

Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Seed Wax, Jojoba Esters, Magnesium Sulfate, PEG-8 Beeswax, Polyglycerin-3,

Polyglyceryl-3 Ricinoleate, Potassium Sorbate, Sodium Benzoate, Sodium Citrate, Sodium Gluconate, Sorbitan Caprylate, Sorbitan

Isostearate, Tocopherol, Vegetable Oil, Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TENA 
zinc oxide protective cream lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59608-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
YELLOW WAX (UNII: 2ZA36H0S2V)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM GLUCONATE (UNII: R6Q3791S76)
SORBITAN (UNII: 6O92ICV9RU)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
TOCOPHEROL (UNII: R0ZB2556P8)
CORN OIL (UNII: 8470G57WFM)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59608-003-10	100 mL in 1 TUBE; Type 0: Not a Combination Product	06/07/2017
2	NDC: 59608-003-05	5 mL in 1 TUBE; Type 0: Not a Combination Product	06/07/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/07/2017

Labeler - SCA Personal Care Inc. (790100549)