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TENA by SCA Personal Care Inc.

Medically reviewed on July 18, 2017

Dosage form: lotion
Ingredients: ZINC OXIDE 10g in 100mL
Labeler: SCA Personal Care Inc.
NDC Code: 59608-003

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.

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.

TENA 
zinc oxide protective cream lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59608-003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC CATION) ZINC CATION10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ACACIA DECURRENS FLOWER WAX 
MEDIUM-CHAIN TRIGLYCERIDES 
CITRIC ACID MONOHYDRATE 
DICAPRYLYL CARBONATE 
ETHYLHEXYLGLYCERIN 
GLYCERIN 
HELIANTHUS ANNUUS SEED WAX 
HYDROGENATED JOJOBA OIL, RANDOMIZED 
MAGNESIUM SULFATE, UNSPECIFIED FORM 
YELLOW WAX 
PHENOXYETHANOL 
POLYGLYCERIN-3 
POLYGLYCERYL-3 RICINOLEATE 
POTASSIUM SORBATE 
SODIUM BENZOATE 
SODIUM CITRATE 
SODIUM GLUCONATE 
SORBITAN 
SORBITAN ISOSTEARATE 
TOCOPHEROL 
CORN OIL 
WATER 
Packaging
#Item CodePackage Description
1NDC:59608-003-10100 mL in 1 TUBE
2NDC:59608-003-055 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/07/2017
Labeler - SCA Personal Care Inc. (790100549)

 
SCA Personal Care Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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