Label: SECURA PERSONAL SKIN CARE KIT- benzethonium chloride,petrolatum kit
-
Contains inactivated NDC Code(s)
NDC Code(s): 69740-343-00 - 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)
- SPL UNCLASSIFIED SECTION
-
DIRECTIONS
- Change wet and soiled diapers, garments, and linens promptly. Spray cleanser liberally on affected area.
- Wipe clean with tissues, and remove soiled underpads and diapers.
- Immediately dispose of tissues and underpads to control odor. Allow to dry. No rinsing necessary.
- Apply protective ointment 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.
- Check patient often. Repeat steps 1-4 after each exposure to feces and urine.
- QUESTIONS
- DRUG FACTS - SECURA◊ PERSONAL CLEANSER
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- INACTIVE INGREDIENTS
- DRUG FACTS - SECURA◊ PROTECTIVE OINTMENT
- 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 ointment 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?
-
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA PERSONAL SKIN CARE KIT
#59434300
NDC 69740-343-00Personal Skin Care Kit
Kit contains:
Antimicrobial Skin Cleanser
SECURA◊ Personal 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-balanced
- Pediatric tested
- CHG compatible
Skin Protectant
SECURA◊ Protective Ointment
2.47 oz. (70 g)
- For treatment and prevention of incontinence-associated dermatitis
- Enriched with Vitamins A, D & E
- Pediatric tested
- CHG compatible
- Enriched with Clove Oil
Smith&NephewSecura◊
Personal Skin Care Kit
- PACKAGE LABEL - SIDE DISPLAY PANEL - SECURA PERSONAL SKIN CARE KIT
-
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA PERSONAL CLEANSER (236mL)
#59430400
NDC 69740-304-00
Personal 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◊
Personal Cleanser
8 fl oz. (236 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, 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. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
DIRECTIONS
- spray cleanser liberally on affected area, then wipe clean
- no rinsing necessary
INACTIVE INGREDIENTS
water, octoxynol-9, sodium citrate, polysorbate 20, propylene glycol, citric acid, diazolidinyl urea, polyquaternium-4, benzyl alcohol, methylparaben, fragrance, disodium EDTA, D&C Red #33
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. and Tm. Off.
-
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA PROTECTIVE OINTMENT (70g)
#59431500
NDC 69740-315-00Protective Ointment
Skin Protectant
- For treatment and prevention of incontinence-associated dermatitis
- Enriched with Vitamins A, D & E
- Pediatric tested
- CHG compatible
- Enriched with Clove Oil
Smith&Nephew
Secura ◊
Protective OintmentNet wt. 2.47 oz (70g)
DRUG FACTS
ACTIVE INGREDIENTS
Petrolatum 98.789%
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 ointment 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
benzyl alcohol, clove oil, o-phenylphenol, tocopheryl acetate, corn oil, retinyl palmitate, cholecalciferol, D&C Green #6
QUESTIONS OR COMMENTS?
1 800 876-1261Made in India for:
Smith & Nephew Medical Ltd101 Hessle Rd, Hull HU3 2BN England
Trademark of Smith & Nephew
Certain marks reg'd U.S. Pat. and Tm. Off.
-
INGREDIENTS AND APPEARANCE
SECURA PERSONAL SKIN CARE KIT
benzethonium chloride,petrolatum kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69740-343 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69740-343-00 1 in 1 CARTON; Type 0: Not a Combination Product 08/01/2003 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, SPRAY 236 mL Part 2 1 TUBE 70 g Part 1 of 2 SECURA PERSONAL CLEANSER
benzethonium chloride sprayProduct Information Item Code (Source) NDC:69740-304 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 3.08 ug in 1 mL D&C RED NO. 33 (UNII: 9DBA0SBB0L) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) 3 uL in 1 mL EDETATE DISODIUM (UNII: 7FLD91C86K) 1 ug in 1 mL METHYLPARABEN (UNII: A2I8C7HI9T) 1 ug in 1 mL OCTOXYNOL 9 (UNII: 7JPC6Y25QS) 20 uL in 1 mL POLYSORBATE 20 (UNII: 7T1F30V5YH) 10 ug in 1 mL PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 10 uL in 1 mL WATER (UNII: 059QF0KO0R) 929.389 uL in 1 mL TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) 171.3 ug 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 Part 2 of 2 SECURA PROTECTIVE
petrolatum ointmentProduct Information Item Code (Source) NDC:69740-315 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 987.89 mg in 1 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) 5 mg in 1 g CLOVE OIL (UNII: 578389D6D0) 3 mg in 1 g D&C GREEN NO. 6 (UNII: 4QP5U84YF7) 0.01 mg in 1 g ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 2 mg in 1 g CHOLECALCIFEROL (UNII: 1C6V77QF41) 0.1 mg in 1 g VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) CORN OIL (UNII: 8470G57WFM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 70 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 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(69740-304, 69740-343) Establishment Name Address ID/FEI Business Operations ENCUBE ETHICALS PVT LTD 915834105 manufacture(69740-315)
