FDA.reportPublic FDA data

Secura Two Step Kit

Manufacturer
Smith & Nephew, Inc. | Swiss-American CDMO, LLC | ENCUBE ETHICALS PVT LTD
Effective date
2016-07-22
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-02 01:25:01

Label at a glance#

ProductSecura Two Step Kit
Active ingredientBENZETHONIUM CHLORIDE, ZINC OXIDE
Label structure19 sections

Indications and uses

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

Dosage and administration

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 ch...

Label contents#

Full prescribing information#

DRUG FACTS - Secura Two Step Kit

DESCRIPTION SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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.

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Benzethonium chloride 0.13%

PURPOSE

OTC - PURPOSE SECTION

Antimicrobial

USES

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

OTC - WHEN USING SECTION

For external use only

OTC - DO NOT USE SECTION

  • Avoid contact with eyes
  • 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

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

QUESTION OR COMMENTS?

OTC - QUESTIONS SECTION

1 800 876-1261

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide 10%

PURPOSE

OTC - PURPOSE SECTION

Skin protectant

USES

INDICATIONS & USAGE SECTION

  • Skin protectant
  • Helps treat and prevent diaper dermatitis
  • Protects minor skin irritation associated with diaper dermatitis and helps seal out wetness

WARNINGS

WARNINGS SECTION

OTC - WHEN USING SECTION

For external use only

OTC - DO NOT USE SECTION


  • Avoid contact with eyes
  • 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

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

1 800 876-1261

PACKAGE LABEL - Secura Two Step Kit

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#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-kitPackage Display - Two-step-kit

PACKAGE LABEL - SECURA MOISTURIZING CLEANSER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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-236mlPackage Display - Moisturizing Cleanser-236ml


PACKAGE DISPLAY PANEL - SECURA PROTECTIVE CREAM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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-78gPackage Display - Protective-Cream-78g

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50484-344-00EA - Each50484-344565c5b6b-36b2-457d-a8a3-23de7b452e1312013-02-13
50484-309-00ML - Milliliter50484-3099f383437-7e7e-4f0f-bd78-dd5d76ec97f612012-07-24
50484-312-00GM - Gram50484-3128d00460c-4569-4c98-8aa9-7c0928850ea212013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZETHONIUM CHLORIDEACTIVE INGREDIENTPH41D057447
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z7
BENZETHONIUMACTIVE MOIETY1VU15B70BP7
ZINCACTIVE MOIETYJ41CSQ7QDS7
ALLANTOININACTIVE INGREDIENT344S277G0Z7
ALOE VERA FLOWERINACTIVE INGREDIENT575DY8C1ER7
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L07
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH7
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S7
CLOVE OILINACTIVE INGREDIENT578389D6D07
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K7
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT28659933097
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD7
GLYCERININACTIVE INGREDIENTPDC6A3C0OX7
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T7
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U7
POLYOXYL 40 CASTOR OILINACTIVE INGREDIENT4ERD2076EF7
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH7
SODIUM CETOSTEARYL SULFATEINACTIVE INGREDIENT7ZBS06BH4B7
WATERINACTIVE INGREDIENT059QF0KO0R7

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50484-34450484-344-00
50484-309
50484-312

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZETHONIUM CHLORIDEPH41D05744ACTIB
BENZYL ALCOHOLLKG8494WBHIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
EDETATE DISODIUM7FLD91C86KIACT
ALOE VERA FLOWER575DY8C1ERIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 207T1F30V5YHIACT
WATER059QF0KO0RIACT
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ALLANTOIN344S277G0ZIACT
CLOVE OIL578389D6D0IACT
METHYLPARABENA2I8C7HI9TIACT
POLYSORBATE 207T1F30V5YHIACT
SODIUM CETOSTEARYL SULFATE7ZBS06BH4BIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
PETROLATUM4T6H12BN9UIACT
ALOE VERA FLOWER575DY8C1ERIACT
ETHYLHEXYL PALMITATE2865993309IACT
POLYOXYL 40 CASTOR OIL4ERD2076EFIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 382 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / SOFT TISSUE23 mgExact identifier — unii candidate
50 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET, COATED / ORAL0.8 mgExact identifier — unii candidate
79 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / SOFT TISSUE40 mgExact identifier — unii candidate
50 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / INTRAVENOUS45 mgExact identifier — unii candidate
79 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCAPSULE / ORAL450 mgExact identifier — unii candidate
50 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCAPSULE, EXTENDED RELEASE / ORAL1.23 mgExact identifier — unii candidate
50 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION/ DROPS / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
18 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPASTE, DENTIFRICE / DENTALNAExact identifier — unii candidate
37 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS144 mgExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION / SUBCUTANEOUSNAExact identifier — unii candidate
28 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / RECTAL0.13 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / ENDOTRACHEAL54 mgExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / INTRAMUSCULAR0.13 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRA-ARTICULAR1 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / RECTAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRA-ARTERIAL0.9 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / TOPICAL0.24 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / VAGINAL6 mgExact identifier — unii candidate
9 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / PARENTERAL18 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KOINTMENT / TOPICAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INFILTRATION80 mgExact identifier — unii candidate
79 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / AURICULAR (OTIC)0.1 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, COATED / ORAL0.52 mgExact identifier — unii candidate
37 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRALESIONAL0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / PERIDURAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TLIQUID / ORAL162 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRALESIONAL0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / ORAL0.5 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRALESIONAL20 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii candidate
50 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCONCENTRATE / ORAL12 mgExact identifier — unii candidate
79 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / TOPICAL2 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, COATED / ORAL0.21 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / TOPICAL0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / INTRAVENOUS0.03 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
37 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUPPOSITORY / VAGINALNAExact identifier — unii candidate
79 equally ranked IID candidates
POLYOXYL 40 CASTOR OILPEG-40 CASTOR OIL4ERD2076EFTABLET / ORAL9 mgExact identifier — unii candidate
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRACAVITARY0.01 mlExact identifier — unii candidate
50 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii candidate
9 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHTABLET, DELAYED RELEASE / ORAL2.31 mgExact identifier — unii candidate
50 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0cb1b4ad-56c4-4228-a8f2-532d5e6105ead66c2fc0-df70-4212-ba78-d6cdf58a234c2016-07-22WarningsExact identifier
spl id: 0cb1b4ad-56c4-4228-a8f2-532d5e6105ea
spl set id: d66c2fc0-df70-4212-ba78-d6cdf58a234c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.