Essity (as PLD) - TENA PROSKIN PROTECTIVE CREAM (11%) (59608-008)

TENA PROSKIN PROTECTIVE by

Drug Labeling and Warnings

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

Drug Details [pdf]

TENA PROSKIN PROTECTIVE- zinc oxide cream 
Essity HMS North America Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Essity (as PLD) - TENA PROSKIN PROTECTIVE CREAM (11%) (59608-008)

ACTIVE INGREDIENT

ZINC OXIDE 11%

PURPOSE

SKIN PROTECTANT

USES

• Helps treat and prevent diaper rash
• Temporarily protects chafed skin due to diaper rash and helps seal out wetness

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. 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 as needed.

OTHER INFORMATION

Store between 32°F and 85°F

INACTIVE INGREDIENTS

Water, Dicaprylyl Carbonate, Caprylic/Capric Triglyceride, Glycerin, Magnesium Sulfate, Polyglyceryl-6 Polyhydroxystearate, Polyglyceryl-6 Polyricinoleate, Octyldodecanol, Phenoxyethanol, Sorbitan Olivate, Sodium Citrate, Sodium Benzoate, Jojoba Esters, Potassium Sorbate, Helianthus Annuus (Sunflower) Seed Wax, Disteardimonium Hectorite, Sodium Gluconate, Propylene Carbonate, Citric Acid, Acacia Decurrens Flower Wax, Polyglycerin-3, Tocopherol, Ascorbyl Palmitate.

QUESTIONS OR COMMENTS?

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

TENA PROSKIN PROTECTIVE 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59608-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	11 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ASCORBYL PALMITATE (UNII: QN83US2B0N)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SORBITAN OLIVATE (UNII: MDL271E3GR)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SODIUM BENZOATE (UNII: OJ245FE5EU)
HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 64-70) (UNII: 96YYQ5TK1K)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SODIUM GLUCONATE (UNII: R6Q3791S76)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59608-008-01	100 mL in 1 TUBE; Type 0: Not a Combination Product	11/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	11/02/2020

Labeler - Essity HMS North America Inc. (787850148)

Revised: 1/2022

Document Id: d66f45ca-70b6-1c0f-e053-2a95a90a6671

34390-5

Set id: c73176dd-a3b6-5c71-e053-2995a90a5312

Version: 2

Effective Time: 20220125