TENA- zinc oxide protective cream lotion 
SCA Personal Care 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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Active Ingredient

Zinc Oxide 10%

Purpose

Skin Protectant

Uses

•helps treat and prevent skin rashes due to incontinence

•protects chafed skin due to incontinence 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® Cleansing Cream and/or TENA® Washcloths

•apply cream sparingly and reapply as needed

Other information Store between 32° F and 85° F

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.

image description

TENA 
zinc oxide protective cream lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59608-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59608-003-10100 mL in 1 TUBE; Type 0: Not a Combination Product06/07/2017
2NDC:59608-003-055 mL in 1 TUBE; Type 0: Not a Combination Product06/07/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/07/2017
Labeler - SCA Personal Care Inc. (790100549)

Revised: 7/2017
Document Id: 4cae6538-9bea-4bdd-8ba6-d4b1b5029791
Set id: fe115e44-e97d-4cbc-8ec8-ebcae7f9e3f3
Version: 3
Effective Time: 20170718
 
SCA Personal Care Inc.