NDC Code(s) : 50484-325-00, 50484-324-00
Packager : Smith & Nephew, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Secura Extra ProtectiveZINC OXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50484-325
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE306.1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE(UNII: 05JZI7B19X)30.6 mg in 1 g
BENZETHONIUM CHLORIDE(UNII: PH41D05744)1.3 mg in 1 g
BUTYLPARABEN(UNII: 3QPI1U3FV8)0.5 mg in 1 g
DIAZOLIDINYL UREA(UNII: H5RIZ3MPW4)2 mg in 1 g
KARAYA GUM(UNII: 73W9IQY50Q)71.4 mg in 1 g
METHYLPARABEN(UNII: A2I8C7HI9T)3.1 mg in 1 g
MINERAL OIL(UNII: T5L8T28FGP)41 mg in 1 g
PETROLATUM(UNII: 4T6H12BN9U)408.2 mg in 1 g
WATER(UNII: 059QF0KO0R)21.6 mg in 1 g
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)2 mg in 1 g
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)61.2 mg in 1 g
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50484-325-00219.7 g in 1.0 TUBE Type 0: Not a Combination Product08/01/2003
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 08/01/2003 08/31/2018
Secura Extra ProtectiveZINC OXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50484-324
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE306.1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE(UNII: 05JZI7B19X)30.6 mg in 1 g
BENZETHONIUM CHLORIDE(UNII: PH41D05744)1.3 mg in 1 g
BUTYLPARABEN(UNII: 3QPI1U3FV8)0.5 mg in 1 g
DIAZOLIDINYL UREA(UNII: H5RIZ3MPW4)2 mg in 1 g
KARAYA GUM(UNII: 73W9IQY50Q)71.4 mg in 1 g
METHYLPARABEN(UNII: A2I8C7HI9T)3.1 mg in 1 g
MINERAL OIL(UNII: T5L8T28FGP)41 mg in 1 g
PETROLATUM(UNII: 4T6H12BN9U)408.2 mg in 1 g
WATER(UNII: 059QF0KO0R)21.6 mg in 1 g
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)2 mg in 1 g
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)61.2 mg in 1 g
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50484-324-0092 g in 1.0 TUBE Type 0: Not a Combination Product08/01/2003
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 08/01/2003 08/31/2018

PRINCIPAL DISPLAY PANEL


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.


Package Display - Tube (92g)


PRINCIPAL DISPLAY PANEL

image description