Label: SECURA TWO STEP KIT- benzethonium chloride and zinc oxide cream kit
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Contains inactivated NDC Code(s)
NDC Code(s): 69740-344-00 - Packager: Smith & Nephew, Medical Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 14, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- #59434400 NDC 69740-344-00
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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.
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. & Tm. Off.
- DRUG FACTS - SECURA◊ MOISTURIZING CLEANSER
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- INACTIVE INGREDIENTS
- DRUG FACTS - SECURA◊ PROTECTIVE CREAM
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
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
- QUESTIONS OR COMMENTS?
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PRINCIPAL DISPLAY PANEL
PACKAGE LABEL (Front)
#59434400
NDC 69740-344-00Two-Step Kit
Kit contains:Antimicrobial Skin Cleanser
SECURA◊ Moisturizing Cleanser
8 fl. oz. (236 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◊ Protective Cream
2.75 oz. (78g)
- For treatment and prevention of incontinence-associated dermatitis
- Pediatric tested
- CHG compatible
- Enriched with allantoin, Vitamin E and Aloe
- Clove Oil controls odor
- Conditions and soothes
smith&nephew
SECURA◊
Two-Step Kit
PACKAGE LABEL (Side)
Two-Step Kit
Kit contains:
SECURA◊ Moisturizing Cleanser8 fl. oz. (236 mL)
SECURA◊ Protective Cream
2.75 oz. (78 g)
smith&nephew
SECURA◊
Two-Step Kit
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PACKAGE LABEL - SECURA MOISTURIZING CLEANSER
Item #59430900
NDC 69740-309-00Moisturizing
CleanserAntimicrobial Skin Cleanser
- No-rinse, one-step cleansing for perineum or body
- Gentle removes urine, feces, and other body fluids
- Reduces odor
- pH-balanced
- Pediatric tested
- CHG compatible
Smith&Nephew
Secura ◊ Moisturizing Cleanser8 fl. oz. (236mL)
DRUG FACTS
ACTIVE INGREDIENTBenzethonium 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 USA for:
Smith & Nephew Medical Ltd
101, Hessle Rd,
Hull HU3 2BN England
www.smith-nephew.com
Trademark of Smith & Nephew
Certain marks reg'd in U.S. Pat. & Tm. Off.
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PACKAGE DISPLAY PANEL - SECURA PROTECTIVE CREAM
Item #59431200
NDC 69740-312-00Protective Cream
Skin Protectant
- For treatment and prevention of incontinence-associated dermatitis
- Pediatric tested
- CHG compatible
- Enriched with Allantoin, Vitamin E and Aloe
- Clove Oil controls odor
- Conditions and soothes
Smith & Nephew
Secura ◊Protective CreamNew wt. 2.75 oz. (78 g)
DRUG FACTS - SECURA PROTECTIVE CREAM
ACTIVE INGREDIENT
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 caster oil, polysorbate 20, octyl palmitate, sodium cetearyl sulfate, octyl stearate, dioctyl adipate, tocopheryl acetate, methylparaben, allantoin, clove oil, o-phenylphenol, aloe barbadensis
QUESTIONS OR COMMENTS?
1 800 867-1261
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. & Tm. Off.
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INGREDIENTS AND APPEARANCE
SECURA TWO STEP KIT
benzethonium chloride and zinc oxide cream kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69740-344 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69740-344-00 1 in 1 CARTON 08/01/2003 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, SPRAY 236 mL Part 2 1 TUBE 78 g Part 1 of 2 SECURA MOISTURIZING CLEANSER
benzethonium chloride sprayProduct Information Item Code (Source) NDC:69740-309 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 1.3 ug in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 236 mL in 1 BOTTLE, SPRAY; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 08/01/2003 Part 2 of 2 SECURA PROTECTIVE
zinc oxide creamProduct Information Item Code (Source) NDC:69740-312 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 100 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 78 g in 1 TUBE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 08/01/2003 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 08/01/2003 Labeler - Smith & Nephew, Medical Ltd. (216344051) Establishment Name Address ID/FEI Business Operations Swiss-America Products, Inc. 080170933 manufacture(69740-309, 69740-344) Establishment Name Address ID/FEI Business Operations ENCUBE ETHICALS PVT LTD 915834105 manufacture(69740-312)