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Secura Personal Skin Care Kit

Dosage form: kit
Ingredients: BENZETHONIUM CHLORIDE 1.3uL in 1mL; PETROLATUM 987.89mg in 1g
Labeler: Smith & Nephew, Inc.
NDC Code: 50484-343

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 Personal Skin Care Kit

DRUG FACTS - SECURA PERSONAL SKIN CARE KIT

Kit information is followed by Drug Facts for the kit contents and related products.

DIRECTIONS
  1. Change wet and soiled diapers, garments, and linens promptly. Spray cleanser liberally on affected area.
  2. Wipe clean with tissues, and remove soiled underpads and diapers.
  3. Immediately dispose of tissues and underpads to control odor. Allow to dry. No rinsing necessary.
  4. Apply protective ointment liberally as often as necessary with each diaper, garment, or linen change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces or urine may be prolonged.
  5. Check patient often. Repeat steps 1-4 after each exposure to feces and urine.

Refer to individual product labeling for detailed instructions.

DRUG FACTS - SECURA PERSONAL CLEANSER (236 mL)

ACTIVE INGREDIENTS

Benzethonium chloride 0.13%

PURPOSE

Antimicrobial

USES
  • Antimicrobial skin cleanser for the perineum or body
  • Aids in the removal of urine, feces, or other foreign material

WARNINGS

  • For external use only
  • Avoid contact with eyes 

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

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

  • Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately

DIRECTIONS
  • spray/apply cleanser liberally on affected area, then wipe clean
  • no rinsing necessary 

INACTIVE INGREDIENTS

water, octoxynol-9, sodium citrate, polysorbate 20, propylene glycol, citric acid, diazolidinyl urea, polyquaternium-4, benzyl alcohol, methylparaben, fragrance, disodium EDTA, D&C Red #33

QUESTION OR COMMENTS?

1 800 876-1261

DRUG FACTS - SECURA PROTECTIVE OINTMENT (70 g)

ACTIVE INGREDIENTS

Petrolatum 98.789%

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 ointment liberally as often as necessary with each diaper, garment or linen change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces, or urine may be prolonged

INACTIVE INGREDIENTS

benzyl alcohol, clove oil, o-phenylphenol, tocopheryl acetate, corn oil, retinyl palmitate, cholecalciferol, D&C Green #6

QUESTIONS OR COMMENTS?

1 800 876-1261


PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA PERSONAL SKIN CARE KIT

#59434300
NDC 50484-343-00

Personal Skin Care Kit

Kit contains:

  • Antimicrobial Skin Cleanser
  • Skin Protectant

Smith&Nephew
Secura
Personal Skin Care Kit


Kit Contains:
SecuraPersonal Cleanser
8 fl. oz. (236mL)

SecuraProtective Ointment
2.47 oz. (70g)


Personal
Skin Care Kit

Good skin care can  help prevent breakdown

Packaged in the USA with products made in USA and India for:
Smith & Nephew, Inc.
St. Petersburg, FL 33716
www.smith-nephew.com
Trademarks of Smith & Nephew. Reg. U.S. Pat. & Tm. Off.


PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA PERSONAL CLEANSER (236mL)

#59430400
NDC 50484-304-00

Personal Cleanser

Antimicrobial Skin Cleanser

  • No-rinse, one-step cleansing for perineum or body
  • Gentle surfactants emulsify stool without friction
  • Reduces odor
  • pH-buffered
  • Pediatrician tested

Smith&Nephew
Secura
Personal Cleanser

8 fl oz. (236mL)


Made 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 - SECURA PROTECTIVE OINTMENT (70g)

#59431500
NDC 50484-315-00

Protective Ointment

Skin Protectant

  • For treatment and prevention of diaper dermatitis associated with exposure to feces or urine
  • Contains Vitamins A, D & E
  • Clove Oil controls odor
  • Pediatrician tested

Smith&Nephew
Secura
Protective Ointment

Net  wt. 2.47 oz (70g)


Made in India for:
Smith & Nephew, Inc., St. Petersburg, FL 33716
Trademark of Smith & Nephew. Reg. U.S. Pat. & Tm. Off.


SECURA PERSONAL SKIN CARE KIT 
benzethonium chloride,petrolatum kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50484-343
Packaging
#Item CodePackage Description
1NDC:50484-343-001 KIT (1 KIT) in 1.0 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, SPRAY 236 mL
Part 21 TUBE 70 g
Part 1 of 2
SECURA PERSONAL CLEANSER 
benzethonium chloride spray
Product Information
Item Code (Source)NDC:50484-304
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (BENZETHONIUM) BENZETHONIUM CHLORIDE1.3 uL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL2 uL  in 1 mL
CITRIC ACID3.08 uL  in 1 mL
D&C RED NO. 33 
DIAZOLIDINYL UREA3 uL  in 1 mL
EDETATE DISODIUM1 uL  in 1 mL
METHYLPARABEN1 uL  in 1 mL
OCTOXYNOL 920 uL  in 1 mL
POLYSORBATE 2010 uL  in 1 mL
PROPYLENE GLYCOL10 uL  in 1 mL
WATER929.389 uL  in 1 mL
TRISODIUM CITRATE DIHYDRATE171.3 uL  in 1 mL
Packaging
#Item CodePackage Description
1236 mL in 1.0 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333
Part 2 of 2
SECURA PROTECTIVE 
petrolatum ointment
Product Information
Item Code (Source)NDC:50484-315
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (PETROLATUM) PETROLATUM987.89 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL5 mg  in 1 g
CLOVE OIL3 mg  in 1 g
D&C GREEN NO. 60.01 mg  in 1 g
ALPHA-TOCOPHEROL ACETATE2 mg  in 1 g
CHOLECALCIFEROL0.1 mg  in 1 g
VITAMIN A PALMITATE 
CORN OIL 
Packaging
#Item CodePackage Description
170 g in 1.0 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart347
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
Establishment
NameAddressID/FEIOperations
Swiss-American Products, Inc.611921669MANUFACTURE

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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