Essity (as PLD) - TENA PROSKIN PROTECTIVE CREAM (59608-007)

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 (59608-007)

ACTIVE INGREDIENT

ZINC OXIDE 10%

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

0-LBL_Tena ProSkin Protectant_100mL_US

TENA PROSKIN PROTECTIVE 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59608-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 59608-007-01100 mL in 1 TUBE; Type 0: Not a Combination Product11/02/202001/20/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/02/202001/20/2022
Labeler - Essity HMS North America Inc. (787850148)

Revised: 1/2022
Document Id: d66f5d2d-15df-0c55-e053-2a95a90aa4ab
Set id: c6bab358-c7d9-62d6-e053-2a95a90a339b
Version: 3
Effective Time: 20220125