Label: SECURA EPC SKIN CARE STARTER KIT- zinc oxide, benzethonium chloride kit
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Contains inactivated NDC Code(s)
NDC Code(s): 69740-341-00 - 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.
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- SPL UNCLASSIFIED SECTION
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DIRECTIONS
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
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- DRUG FACTS - SECURA◊ EXTRA PROTECTIVE CREAM ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
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PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA EPC SKIN CARE STARTER KIT
#59434100
NDC 69740-341-00
EPC Skin Care Starter Kit
Kit contains:
Antimicrobial Skin CleanserSecura◊ 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 compatibleSkin 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 compatibleSmith&Nephew
Secura◊
EPC Skin Care Starter Kit
- PACKAGE LABEL - SIDE DISPLAY PANEL - SECURA EPC SKIN CARE STARTER KIT
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PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA EXTRA PROTECTIVE CREAM - TUBE (92 g)
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 CreamNet 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 wetnessWARNINGS
• 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 immediatelyDIRECTIONS
• 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 prolongedOTHER 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.
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PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA MOISTURIZING CLEANSER - BOTTLE (118 mL)
Item #59430800
NDC 69740-308-00
Moisturizing CleanserAntimicrobial 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 materialWARNINGS
• 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 immediatelyDIRECTIONS
• apply cleanser liberally on affected area, then wipe clean
• no rinsing necessaryINACTIVE 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.
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INGREDIENTS AND APPEARANCE
SECURA EPC SKIN CARE STARTER KIT
zinc oxide, benzethonium chloride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69740-341 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69740-341-00 1 in 1 CONTAINER 08/01/2003 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 92 g Part 2 1 BOTTLE, SPRAY 118 mL Part 1 of 2 SECURA EXTRA PROTECTIVE
zinc oxide creamProduct Information Item Code (Source) NDC:69740-324 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 306.1 mg in 1 g Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) 30.6 mg in 1 g WATER (UNII: 059QF0KO0R) 21.6 mg in 1 g PETROLATUM (UNII: 4T6H12BN9U) 408.2 mg in 1 g MINERAL OIL (UNII: T5L8T28FGP) 41 mg in 1 g METHYLPARABEN (UNII: A2I8C7HI9T) 3.1 mg in 1 g KARAYA GUM (UNII: 73W9IQY50Q) 71.4 mg in 1 g DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) 2 mg in 1 g BUTYLPARABEN (UNII: 3QPI1U3FV8) 0.5 mg in 1 g BENZETHONIUM CHLORIDE (UNII: PH41D05744) 1.3 mg in 1 g ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 2 mg in 1 g CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 61.2 mg in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 92 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 Part 2 of 2 SECURA MOISTURIZING CLEANSER
benzethonium chloride sprayProduct Information Item Code (Source) NDC:69740-308 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 ALOE (UNII: V5VD430YW9) 0.05 ug in 1 mL BENZYL ALCOHOL (UNII: LKG8494WBH) 2 uL in 1 mL EDETATE DISODIUM (UNII: 7FLD91C86K) 0.2 ug in 1 mL FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.001 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 1 118 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 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(69740-308, 69740-341) Establishment Name Address ID/FEI Business Operations ENCUBE ETHICALS PVT LTD 915834105 manufacture(69740-324)
