Secura Extra Protective

Dosage form: cream
Ingredients: ZINC OXIDE 306.1mg in 1g
Labeler: Smith & Nephew, Inc.
NDC Code: 50484-325

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.

Secura Extra Protective Cream

DRUG FACTS

ACTIVE INGREDIENTS

Zinc Oxide 30.6%

PURPOSE

Skin protectant

USES
  • Skin protectant
  • Helps treat and prevent diaper dermatitis
  • Protects minor skin irritation associated with diaper dermatitis and helps seal out wetness 

WARNINGS
  • For external use only

  • Avoid contact with eyes

  • Not to be applied over deep or puncture wounds, infections, or lacerations

  • If condition worsens or does not improve within 7 days, contact a doctor

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

DIRECTIONS
  • change wet and soiled diapers, garments and linens promptly
  • cleanse the affected area and allow to dry
  • apply cream liberally as often as necessary with each diaper change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces, or urine may be prolonged

OTHER INFORMATION

Store at controlled room temperature 59oF-86oF (15oC-30oC)

INACTIVE INGREDIENTS

petrolatum, karaya gum, cetearyl alcohol, methyl glucose dioleate, mineral oil, cellulose gum, water, methylparaben, tocopheryl acetate, diazolidinyl urea, benzethonium chloride, butylparaben

QUESTION OR COMMENTS?

1 800 876-1261


PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - TUBE (92g)

Item #59432400

NDC 50484-324-00

Extra Protective Cream


Skin Protectant

  • For treatment and prevention of incontinence-associated dermatitis
  • For use on denuded skin associated with exposure to feces or urine
  • Adheres to macerated skin
  • Resists wash-off
  • Pediatrician tested

Smith & Nephew

Secura

Extra Protective Cream


Made in India for:
Smith & Nephew, Inc., St. Petersburg, FL 33716

www.smith-nephew.com

Trademark of Smith & Nephew Reg. U.S. Pat. & Tm. Off.



SECURA EXTRA PROTECTIVE 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50484-325
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC) ZINC OXIDE306.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE30.6 mg  in 1 g
BENZETHONIUM CHLORIDE1.3 mg  in 1 g
BUTYLPARABEN0.5 mg  in 1 g
DIAZOLIDINYL UREA2 mg  in 1 g
KARAYA GUM71.4 mg  in 1 g
METHYLPARABEN3.1 mg  in 1 g
MINERAL OIL41 mg  in 1 g
PETROLATUM408.2 mg  in 1 g
WATER21.6 mg  in 1 g
ALPHA-TOCOPHEROL ACETATE2 mg  in 1 g
CETOSTEARYL ALCOHOL61.2 mg  in 1 g
Packaging
#Item CodePackage Description
1NDC:50484-325-00219.7 g in 1.0 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34708/01/2003
SECURA EXTRA PROTECTIVE 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50484-324
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC) ZINC OXIDE306.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE30.6 mg  in 1 g
BENZETHONIUM CHLORIDE1.3 mg  in 1 g
BUTYLPARABEN0.5 mg  in 1 g
DIAZOLIDINYL UREA2 mg  in 1 g
KARAYA GUM71.4 mg  in 1 g
METHYLPARABEN3.1 mg  in 1 g
MINERAL OIL41 mg  in 1 g
PETROLATUM408.2 mg  in 1 g
WATER21.6 mg  in 1 g
ALPHA-TOCOPHEROL ACETATE2 mg  in 1 g
CETOSTEARYL ALCOHOL61.2 mg  in 1 g
Packaging
#Item CodePackage Description
1NDC:50484-324-0092 g in 1.0 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34708/01/2003
Labeler - Smith & Nephew, Inc. (827731451)
Registrant - ENCUBE ETHICALS PVT LTD (915834105)
Establishment
NameAddressID/FEIOperations
ENCUBE ETHICALS PVT LTD915834105MANUFACTURE

Revised: 05/2010
 
Smith & Nephew, 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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