SECURA EPC SKIN CARE STARTER KIT zinc oxidebenzethonium chloride

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)
Available from:
Smith & Nephew, Inc.
INN (International Name):
ZINC OXIDE
Composition:
ZINC CATION 306.1 mg in 1 g
Prescription type:
OTC DRUG
Authorization status:
OTC monograph not final

SECURA EPC SKIN CARE STARTER KIT- zinc oxide,benzethonium chloride

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 EPC Skin Care Starter Kit

DRUG FACTS - SECURA EPC SKIN CARE STARTER KIT

Refer to individual product labeling for detailed instructions.

DRUG FACTS - SECURA EXTRA PROTECTIVE CREAM

ACTIVE INGREDIENT

Zinc Oxide 30.6%

PURPOSE

Skin protectant

USES

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

DRUG FACTS - SECURA MOISTURIZING CLEANSER

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,

D&C Blue #1

QUESTIONS OR COMMENTS?

1 800 876-1261

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

KIT

#59434100

NDC 50484-341-00

EPC Skin Care Starter Kit

Antimicrobial Skin Cleanser

Secura Moisturizing Cleanser 4 fl. oz. (118mL)

Provides one-step no-rinse cleansing for perineum and body; saves time

Pediatrician-tested

Skin Protectant

Secura Extra Protective Cream 3.25 oz. (92g)

Helps treat and prevent diaper dermatitis

Contains Karaya to adhere to macerated skin

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.

Smith&Nephew

Secura

EPC Skin Care Starter Kit

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA EXTRA PROTECTIVE

CREAM - TUBE (92g)

Item #59432400

NDC 50484-324-00

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

Resists wash-off

Pediatrician tested

Smith & Nephew

Secura

Extra 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.

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA MOISTURIZING CLEANSER

- BOTTLE (118mL)

Item #59430800

NDC 50484-308-00

Moisturizing Cleanser

Antimicrobial Skin Cleanser

No-rinse, one-step cleansing for perineum or body

Gentle surfactants emulsify stool without friction

Reduces Odor

pH-balanced

Contains Aloe and Glycerin to condition, soothe and moisturize skin

Pediatrician-tested

Smith & Nephew

Secura

Moisturizing Cleanser

Made for:

Smith & Nephew, Inc., St. Petersburg, FL 33773

www.smith-nephew.com

Trademark of Smith & Nephew Reg. U.S. Pat. & Tm. Off.

SECURA EPC SKIN CARE STARTER KIT

zinc oxide,benzethonium chloride kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:50 48 4-341

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:50 48 4-341-

1 in 1.0 CONTAINER; Type 1: Co nvenience Kit o f Co -

Pa c ka ge

0 8 /0 1/20 0 3

0 7/30 /20 18

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 TUBE

9 2 g

Pa rt 2

1 BOTTLE, SPRAY

118 mL

Part 1 of 2

SECURA EXTRA PROTECTIVE

zinc oxide cream

Product Information

Ite m Code (Source )

NDC:50 48 4-324

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8 SF37)

ZINC CATION

30 6 .1 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

CARBO XYMETHYLCELLULO SE (UNII: 0 5JZI7B19 X)

WATER (UNII: 0 59 QF0 KO0 R)

PETRO LATUM (UNII: 4T6 H12BN9 U)

MINERAL O IL (UNII: T5L8 T28 FGP)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

KARAYA GUM (UNII: 73W9 IQY50 Q)

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

BUTYLPARABEN (UNII: 3QPI1U3FV8 )

BENZETHO NIUM CHLO RIDE (UNII: PH41D0 5744)

ALPHA-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

9 2 g in 1.0 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt347

0 8 /0 1/20 0 3

0 7/30 /20 18

Part 2 of 2

SECURA MOISTURIZING CLEANSER

benzethonium chloride spray

Product Information

Ite m Code (Source )

NDC:50 48 4-30 8

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZETHO NIUM CHLO RIDE (UNII: PH41D0 5744) (BENZETHONIUM -

UNII:1VU15B70 BP)

BENZETHONIUM

CHLORIDE

1.3 ug

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ALO E (UNII: V5VD430 YW9 )

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

GLYCERIN (UNII: PDC6 A3C0 OX)

PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item

Co de

Package Description

Marketing Start

Date

Marketing End

Date

1

118 mL in 1.0 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

0 8 /0 1/20 0 3

0 7/30 /20 18

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt347

0 8 /0 1/20 0 3

0 7/30 /20 18

Labeler -

Smith & Nephew, Inc. (827731451)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Smith & Nephew, Inc.

Swiss-American CDMO, LLC

0 8 0 170 9 33

MANUFACTURE(50 48 4-324, 50 48 4-341)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

ENCUBE ETHICALS PVT LTD

9 158 3410 5

MANUFACTURE(50 48 4-341)

Revised: 7/2016

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