Medication Guide App

TENA Protective Cream

Dosage form: cream
Ingredients: ZINC OXIDE 100mg in 1mL
Labeler: SCA Personal Care Inc.
NDC Code: 59608-001

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.

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 with Zinc

Crema protectora con zinc

Scent Free

Sin fragancia

for dry & irritated skin

para piel seca e irritada

Quality and Safety Documented

Calidad y Sequridad Comprobadas

TENA PROTECTIVE CREAM 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59608-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CANOLA OIL 
TRICAPRIN 
GLYCERIN 
POLYGLYCERYL-3 RICINOLEATE 
WHITE WAX 
ETHYLHEXYL STEARATE 
HYDROGENATED SOYBEAN OIL 
HYDROGENATED RAPESEED OIL 
HYDROGENATED COCONUT OIL 
BETAINE 
GLYCERYL OLEATE 
PANTHENOL 
MAGNESIUM SULFATE 
.ALPHA.-TOCOPHEROL ACETATE 
MAGNESIUM STEARATE 
MAGNESIUM PALMITATE 
PHENOXYETHANOL 
BENZOIC ACID 
DEHYDROACETIC ACID 
Packaging
#Item CodePackage Description
1NDC:59608-001-0210 TUBE in 1 BOX
1100 mL in 1 TUBE
2NDC:59608-001-01100 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/03/2013
Labeler - SCA Personal Care Inc. (790100549)
Establishment
NameAddressID/FEIOperations
Cederroth AB632468641manufacture(59608-001), label(59608-001), pack(59608-001)

Revised: 10/2013
 
SCA Personal Care Inc.

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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