TENA PROTECTIVE CREAM- zinc oxide cream

TENA Protective Cream by

Drug Labeling and Warnings

TENA Protective 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]

Drug Facts

Active ingredient

Zinc Oxide 10%

Purpose

Skin Protectant

Uses

• helps treat and prevent minor skin irritation assoicated with incontinence
• protects and helps relieve chafed, chapped or cracked skin

Warnings

For external use only

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 right away

Directions

• gently cleanse skin as required
• apply cream sparingly to affected area and reapply as needed

Other information

• store at a temperature between 32°Fand 85°F

Inactive ingredients

benzoic acid, betaine, canola oil, caprylic/capric triglyceride, cera alba, dehydroacetic acid, ethylhexyl stearate, glycerin, glyceryl oleate, hydrogenated vegetable oil, magnesium stearate, magnesium sulfate, panthenol, phenoxyethanol, polyglyceryl-3 ricinoleate, tocopheryl acetate, water

 Questions or comments?

Call 1-800-992-9939 or visit www.tena-usa.com

Principal Display Panel

TENA Protective Cream

Irritated & sensitive skin

Scent Free

10% zinc oxide

INGREDIENTS AND APPEARANCE

TENA PROTECTIVE CREAM 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59608-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CANOLA OIL (UNII: 331KBJ17RK)
TRICAPRIN (UNII: O1PB8EU98M)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
WHITE WAX (UNII: 7G1J5DA97F)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
HYDROGENATED RAPESEED OIL (UNII: K168T6Y0YU)
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)
BETAINE (UNII: 3SCV180C9W)
GLYCERYL OLEATE (UNII: 4PC054V79P)
PANTHENOL (UNII: WV9CM0O67Z)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MAGNESIUM PALMITATE (UNII: JJ0UR696JR)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59608-001-02	10 in 1 BOX	10/03/2013
1		100 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 59608-001-01	100 mL in 1 TUBE; Type 0: Not a Combination Product	10/03/2013
3	NDC: 59608-001-04	500 in 1 CASE	10/03/2013
3		5 mL in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 59608-001-03	5 mL in 1 PACKET; Type 0: Not a Combination Product	10/03/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/03/2013

Labeler - Essity HMS North America Inc (787850148)