Secura Two Step Kit by Smith & Nephew, Inc. / Swiss-American CDMO, LLC / ENCUBE ETHICALS PVT LTD Secura Two Step Kit

Secura Two Step Kit by

Drug Labeling and Warnings

Secura Two Step Kit by is a Otc medication manufactured, distributed, or labeled by Smith & Nephew, Inc., Swiss-American CDMO, LLC, ENCUBE ETHICALS PVT LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SECURA TWO STEP KIT- benzethonium chloride and zinc oxide 
Smith & Nephew, Inc.

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.

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Secura Two Step Kit

DRUG FACTS - Secura Two Step Kit

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

DIRECTIONS

Good skin care can help prevent breakdown.

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 cream 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 MOISTURIZING CLEANSER

ACTIVE INGREDIENTS

Benzethonium chloride 0.13%

PURPOSE

Antimicrobial

USES

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

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

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

INACTIVE INGREDIENTS

water, polysorbate 20, glycerin, polyquaternium-10, benzyl alcohol, fragrance, disodium EDTA, aloe barbadensis, FD&C Blue #1

QUESTION OR COMMENTS?

1 800 876-1261

DRUG FACTS - SECURA PROTECTIVE CREAM

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 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, garment 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

QUESTIONS

1 800 876-1261

PACKAGE LABEL - Secura Two Step Kit

#59434400
NDC 50484-344-00

Two-Step Kit
Kit contains:

  • Antimicrobial Skin Cleanser
  • Skin Protectant

smith&nephew
SECURA◊Two-Step Kit

Kit contains:

SECURA◊ Moisturizing Cleanser
8 fl. oz. (236mL)

SECURA◊ Protective Cream
2.75 oz. (78g)

Two-Step 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 Display - Two-step-kit

PACKAGE LABEL - SECURA MOISTURIZING CLEANSER

Item #59430900
NDC 50484-309-00

Moisturizing
Cleanser

Antimicrobial Skin Cleanser

  • No-rinse, one-step cleansing for perineum or body
  • Gentle surfactants emulsify stool without friction
  • Reduces odor
  • Non-irritating
  • pH-balanced
  • Contains Aloe and Glycerin to condition, soothe, and moisturize skin
  • Pediatrician-tested

Smith&Nephew
Secura◊
Moisturizing 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 Display - Moisturizing Cleanser-236ml


PACKAGE DISPLAY PANEL - SECURA PROTECTIVE CREAM

Item #59431200
NDC 50484-312-00

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

2.75 oz. (78g)

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 - Protective-Cream-78g

SECURA TWO STEP KIT 
benzethonium chloride and zinc oxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50484-344
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50484-344-001 in 1 CARTON; Type 1: Convenience Kit of Co-Package08/01/200301/31/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, SPRAY 236 mL
Part 21 TUBE 78 g
Part 1 of 2
SECURA MOISTURIZING CLEANSER 
benzethonium chloride spray
Product Information
Item Code (Source)NDC: 50484-309
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE1.3 ug  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH) 2 uL  in 1 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.001 ug  in 1 mL
EDETATE DISODIUM (UNII: 7FLD91C86K) 0.2 ug  in 1 mL
ALOE VERA FLOWER (UNII: 575DY8C1ER) 0.05 ug  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) 10 ug  in 1 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH) 30 ug  in 1 mL
WATER (UNII: 059QF0KO0R) 945.94 uL  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A
Part 2 of 2
SECURA PROTECTIVE 
zinc oxide cream
Product Information
Item Code (Source)NDC: 50484-312
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 597.125 mg  in 1 g
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 89 mg  in 1 g
ALLANTOIN (UNII: 344S277G0Z) 2 mg  in 1 g
CLOVE OIL (UNII: 578389D6D0) 2 mg  in 1 g
METHYLPARABEN (UNII: A2I8C7HI9T) 3 mg  in 1 g
POLYSORBATE 20 (UNII: 7T1F30V5YH) 10 mg  in 1 g
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B) 7 mg  in 1 g
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 5 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) 150 mg  in 1 g
ALOE VERA FLOWER (UNII: 575DY8C1ER) 0.375 mg  in 1 g
ETHYLHEXYL PALMITATE (UNII: 2865993309) 8 mg  in 1 g
POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF) 14 mg  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
178 g in 1.0 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart347
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/01/200301/31/2020
Labeler - Smith & Nephew, Inc. (827731451)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO, LLC080170933MANUFACTURE(50484-344, 50484-309)
Establishment
NameAddressID/FEIBusiness Operations
ENCUBE ETHICALS PVT LTD915834105MANUFACTURE(50484-312)

Revised: 7/2016
Document Id: 0cb1b4ad-56c4-4228-a8f2-532d5e6105ea
Set id: d66c2fc0-df70-4212-ba78-d6cdf58a234c
Version: 8
Effective Time: 20160722
 
Smith & Nephew, Inc.