Secura EPC Skin Care Starter Kit

Manufacturer
Smith & Nephew Medical Ltd | Swiss-America Products, Inc. | ENCUBE ETHICALS PVT LTD
Effective date
2017-12-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:08:43

Label at a glance#

ProductSecura EPC Skin Care Starter Kit
Active ingredientZINC OXIDE, BENZETHONIUM CHLORIDE
Label structure22 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

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...

Storage and handling

Store at controlled room temperature 59˚F-86˚F (15˚C-30˚C)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

​#59434100

NDC 69740-341-00

EPC Skin Care Starter Kit

​Good skin care can help prevent breakdown.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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 unrine 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.

Packaged in the USA with products made in USA and India for:
Smith & Nephew Medical Ltd, 101 Hessle Road, Hull HU3 2BN England.
www.smith-nephew.com
*Trademarks of Smith & Nephew
Certain marks reg’d U.S. Pat. and Tm. Off.

DRUG FACTS - SECURA◊ MOISTURIZING CLEANSER ACTIVE INGREDIENT

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

• 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

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

INSTRUCTIONS FOR USE SECTION

• apply 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

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

​1 800 876-1261

DRUG FACTS - SECURA◊ EXTRA PROTECTIVE CREAM ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 30.6%

PURPOSE

OTC - PURPOSE SECTION

Skin protectant

USES

INDICATIONS & USAGE SECTION

• helps treat and prevent diaper dermatitis
• protects minor skin irritation associated with diaper dermatitis and helps seal out wetness

WARNINGS

WARNINGS SECTION

• 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

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

INSTRUCTIONS FOR USE 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 change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces or urine may be prolonged

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Store at controlled room temperature 59˚F-86˚F (15˚C-30˚C)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

petrolatum, karaya gum, cetearyl alcohol, methyl glucose dioleate, mineral oil, cellulose gum, water, methylparaben, tocopheryl acetate, diazolidinyl urea, benzethonium chloride, butylparaben

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA EPC SKIN CARE STARTER KIT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#59434100


NDC 69740-341-00


EPC Skin Care Starter Kit


Kit contains:


Antimicrobial Skin Cleanser

Secura◊ Moisturizing Cleanser

4 fl. oz. (118 mL)
• No-rinse, one-step cleansing for perineum or body
• Gently removes urine, feces, and other body fluids
• Reduces odor
• pH-buffered
• Pediatric tested
• CHG compatible

Skin Protectant

Secura◊ Extra Protective Cream

3.25 oz. (92 g)
• For treatment and prevention of incontinence-associated dermatitis
• For use on denuded skin associated with exposure to feces or urine
• Adheres to macerated skin
• Pediatric tested
• CHG compatible

Smith&Nephew
Secura◊
EPC Skin Care Starter Kit

EPC Main cartonEPC Main carton

PACKAGE LABEL - SIDE DISPLAY PANEL - SECURA EPC SKIN CARE STARTER KIT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#59434100


NDC 69740-341-00


EPC Skin Care Starter Kit


Kit contains:


Secura◊ Moisturizing Cleanser

4 fl. oz. (118 mL)


Secura◊ Extra Protective Cream

3.25 oz. (92 g)

Smith&Nephew
Secura◊
EPC Skin Care Starter Kit

EPC side labelEPC side label

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA EXTRA PROTECTIVE CREAM - TUBE (92 g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Item #59432400


NDC 69740-324-00


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
• Pediatric tested
• CHG compatible


Smith & Nephew


Secura◊


Extra Protective Cream

Net wt. 3.25 oz. (92 g)

DRUG FACTS

ACTIVE INGREDIENT

​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
• 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 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˚F-86˚F (15˚C-30˚C)

​INACTIVE INGREDIENTS

petrolatum, karaya gum, cetearyl alcohol, methyl glucose dioleate, mineral oil, cellulose gum, water, methylparaben, tocopheryl acetate, diazolidinyl urea, benzethonium chloride, butylparaben

​Questions or comments?

​1 800 876-1261

Made in India for
Smith & Nephew Medical Ltd
101 Hessle Rd, Hull HU3 2BN England.
*Trademark of Smith & Nephew
Certain marks reg’d U.S. Pat. and Tm. Off.

92g Protective Cream92g Protective Cream

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA MOISTURIZING CLEANSER - BOTTLE (118 mL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Item #59430800


NDC 69740-308-00


Moisturizing Cleanser

Antimicrobial Skin Cleanser
• No-rinse, one-step cleansing for perineum or body
• Gently removes urine, feces, and other body fluids
• Reduces odor
• pH-balanced
• Pediatric tested
• CHG compatible


Smith&Nephew


Secura◊


Moisturizing Cleanser


4 fl. oz. (118 mL)

​DRUG FACTS

​ACTIVE INGREDIENT

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

​QUESTIONS OR COMMENTS?

​1 800 876-1261

Made in the USA for Smith & Nephew Ltd, 101 Hessle Rd, Hull HU3 2BN England.
www.smith-nephew.com
◊Trademark of Smith & Nephew


Certain marks reg’d in U.S. Pat. and Tm. Off.

118 mL Cleanser118 mL Cleanser

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69740-341-002024-12-16C16284748780-1f386c649-ae27-0266-e053-dadaa90a7c1aSecura EPC Skin Care Starter Kit
69740-341-002023-01-30C16284748780-1f386c649-ae27-0266-e053-dadaa90a7c1aSecura EPC Skin Care Starter Kit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69740-324-00GM - Gram69740-324caec3a42-2d5e-4396-8c9c-13b3b80b5b5712025-01-14

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69740-308
69740-34169740-341-00
69740-324

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Source Document#

Source XML

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Secura Extra ProtectiveZINC OXIDESmith & Nephew Medical Ltd499a1944-1682-4798-9058-3748a5eaa4202025-04-17WarningsExact identifier
ndc (product): 69740-324
296795f0-7eea-96cb-e063-6294a90ad15d645a8c2f-bb27-4dba-8e85-cc1d81b2bb682024-12-16WarningsExact identifier
spl set id: 645a8c2f-bb27-4dba-8e85-cc1d81b2bb68
Secura Moisturizing CleanserBENZETHONIUM CHLORIDESmith & Nephew Medical Ltd337e4ea5-5c41-41dc-811c-e44d382698472024-08-16WarningsExact identifier
ndc (product): 69740-308

Reported adverse events (FAERS/openFDA)#

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