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Secura Protective by Smith & Nephew, Inc.

Medically reviewed on May 3, 2018

Dosage form: cream
Ingredients: ZINC OXIDE 100mg in 1g
Labeler: Smith & Nephew, Inc.
NDC Code: 50484-312

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 Protective Cream

DRUG FACTS

ACTIVE INGREDIENTS

Zinc oxide 10%

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 the 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, garmet or linen change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces, or urine may be prolonged

INACTIVE INGREDIENTS

water, petrolatum, cetearyl alcohol, PEG-40 castor oil, polysorbate 20, octyl palmitate, sodium cetearyl sulfate, octyl stearate, dioctyl adipate, tocopheryl acetate, methylparaben, allantoin, clove oil, o-phenylphenol, aloe barbadensis

QUESTION OR COMMENTS?

1 800 876-1261

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- TUBE (50g)

Item #59431100

NDC 50484-311-00

Protective Cream

Skin Protectant

  • For treatment and prevention of dermatitis associated with exposure to feces or urine
  • Contains Allantoin and Vitamin E
  • Clove Oil controls odor
  • Conditions and soothes
  • Pediatrician tested

Smith & Nephew

Secura

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 PROTECTIVE 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50484-312
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER597.125 mg  in 1 g
ALLANTOIN2 mg  in 1 g
CLOVE OIL2 mg  in 1 g
METHYLPARABEN3 mg  in 1 g
POLYSORBATE 2010 mg  in 1 g
SODIUM CETOSTEARYL SULFATE7 mg  in 1 g
ALPHA-TOCOPHEROL ACETATE5 mg  in 1 g
PETROLATUM150 mg  in 1 g
ALOE VERA FLOWER0.375 mg  in 1 g
CETOSTEARYL ALCOHOL89 mg  in 1 g
POLYOXYL 40 CASTOR OIL14 mg  in 1 g
ETHYLHEXYL PALMITATE8 mg  in 1 g
Packaging
#Item CodePackage Description
1NDC:50484-312-0078 g in 1.0 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/01/200307/31/2020
SECURA PROTECTIVE 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50484-311
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN2 mg  in 1 g
ALOE0.375 mg  in 1 g
SODIUM CETOSTEARYL SULFATE7 mg  in 1 g
CLOVE OIL2 mg  in 1 g
METHYLPARABEN3 mg  in 1 g
POLYSORBATE 2010 mg  in 1 g
WATER597.125 mg  in 1 g
ALPHA-TOCOPHEROL ACETATE5 mg  in 1 g
PETROLATUM150 mg  in 1 g
CETOSTEARYL ALCOHOL89 mg  in 1 g
POLYOXYL 40 CASTOR OIL14 mg  in 1 g
ETHYLHEXYL PALMITATE8 mg  in 1 g
Packaging
#Item CodePackage Description
1NDC:50484-311-0050 g in 1.0 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/01/200307/31/2020
Labeler - Smith & Nephew, Inc. (827731451)
Establishment
NameAddressID/FEIOperations
ENCUBE ETHICALS PVT LTD915834105MANUFACTURE(50484-311), manufacture(50484-312)

 
Smith & Nephew, 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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