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

Otc - when using section

  • Avoid contact with eyes

Otc - do not use section

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

Otc - stop use section

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

Otc - keep out of reach of children section

  • 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 59 oF-86 oF (15 oC-30 oC)

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?

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Ingredients and appearance - Product information

Secura extra protective cream- Zinc oxide

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 50484-325
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Zinc oxide ( UNII: SOI2LOH54Z)( Zinc oxide - UNII: SOI2LOH54Z ) 306.1 mgin 1 g

Inactive Ingredients

Ingredient Name Code
Carboxymethylcellulose ( UNII: 05JZI7B19X)
Benzethonium chloride ( UNII: PH41D05744)
Butylparaben ( UNII: 3QPI1U3FV8)
Diazolidinyl urea ( UNII: H5RIZ3MPW4)
Karaya gum ( UNII: 73W9IQY50Q)
Methylparaben ( UNII: A2I8C7HI9T)
Mineral oil ( UNII: T5L8T28FGP)
Petrolatum ( UNII: 4T6H12BN9U)
Water ( UNII: 059QF0KO0R)
Alpha-tocopherol acetate ( UNII: 9E8X80D2L0)
Cetostearyl alcohol ( UNII: 2DMT128M1S)

Product Characteristics

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 50484-325-00 219.7g in 1 TUBE 2003/08/01

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part347 USA 2003/08/01

Secura extra protective cream- Zinc oxide

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 50484-324
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Zinc oxide ( UNII: SOI2LOH54Z)( Zinc oxide - UNII: SOI2LOH54Z ) 306.1 mgin 1 g

Inactive Ingredients

Ingredient Name Code
Carboxymethylcellulose ( UNII: 05JZI7B19X)
Benzethonium chloride ( UNII: PH41D05744)
Butylparaben ( UNII: 3QPI1U3FV8)
Diazolidinyl urea ( UNII: H5RIZ3MPW4)
Karaya gum ( UNII: 73W9IQY50Q)
Methylparaben ( UNII: A2I8C7HI9T)
Mineral oil ( UNII: T5L8T28FGP)
Petrolatum ( UNII: 4T6H12BN9U)
Water ( UNII: 059QF0KO0R)
Alpha-tocopherol acetate ( UNII: 9E8X80D2L0)
Cetostearyl alcohol ( UNII: 2DMT128M1S)

Product Characteristics

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 50484-324-00 92g in 1 TUBE 2003/08/01

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part347 USA 2003/08/01

Labeler - Smith & Nephew, Inc.( 827731451)

Establishment

Name ID/FEI Business Operations
Smith & Nephew, Inc. 827731451 MANUFACTURE( 50484-324), manufacture( 50484-325)

Package label.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 label.principal display panel