FDA Label for Secura Starter Kit

View Indications, Usage & Precautions

Secura Starter Kit Product Label

The following document was submitted to the FDA by the labeler of this product Smith & Nephew Medical Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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#59434200

NDC 69740-342-00

Starter Kit

Good skin care can help prevent breakdown.


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.
  • Moisturize skin daily and after bathing to prevent dryness.
  • Refer to individual product labeling for detailed instructions.


    Packaged in the USA with products made in the 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.

    • apply cleanser liberally on the affected area, then wipe clean
    • no rinsing necessary
    • • 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


Drug Facts - Secura Moisturizing Cleanser Active Ingredient



Benzethonium chloride 0.13%


Purpose



Antimicrobial

Skin protectant


Uses



  • antimicrobial skin cleanser for the perineum or body
  • aids in the removal of urine, feces, or other foreign material
  • • Skin protectant
    • Helps treat and prevent diaper dermatitis
    • Protects minor skin irritation associated with diaper dermatitis and helps seal out wetness


Warning



  • For external use only
  • Avoid contact with eyes
    • Not to be applied over deep puncture wounds, infections, or lacerations.
      • If condition worsens or does not improve within 7 days, consult a doctor.

Otc - Keep Out Of Reach Of Children



  • Keep out of reach of children. If swallowed, get medical help or contact a Poisin Control Center immediately.
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.


Inactive Ingredients



water, polysorbate 20, glycerin, polyquaternium-10, benzyl alcohol, fragrance, disodium EDTA, aloe barbadensis, FD&C Blue #1

benzyl alcohol, clove oil, o-phenylphenol, tocopheryl acetate, corn oil, retinyl palmitate, cholecalciferol, D&C Green #6


Drug Facts - Secura Protective Ointment Active Ingredient



Petrolatum 98.789%


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.


Questions Or Comments?



1 800 876-1261


Package Label - Principal Display Panel - Secura Starter Kit



#59434200
NDC 69740-342-00

Starter 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 Ointment
2.47 oz (70 g)
• For treatment and prevention of incontinence-associated dermatitis
• Emriched with Vitamins A, D, & E
• Pediatric tested
• CHG compatible
• Enriched with Clove Oil


Moisturizer
Secura Moisturizing Cream
3 fl oz (85 g)
• Nourishes, hydrates and restores moisture to dry skin
• Enriched with Vitamin E
• Absorbs quickly, non-greasy
• Fortifies moisture balance
• Lanolin-free
• CHG compatible


Smith&Nephew
Secura
Starter Kit


Package Label - Side Display Panel - Secura Starter Kit



#59434200
NDC 69740-342-00

Starter Kit

Kit contains


Antimicrobial Skin Cleanser


Secura Moisturizing Cleanser
8 fl. oz. (236 mL)

Skin Protectant


Secura Protective Ointment
2.47 oz. (70 g)

Moisturizer


Secura Moisturizing Cream
3 fl. oz (85 g)

Smith&Nephew
Secura
Starter Kit


Package Label - Principal Display Panel - Secura Moisturizing Cleanser - Bottle (236 Ml)



Item #59430900


NDC 69740-309-00


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


8 fl. oz. (236 mL)


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, 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, consult 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. and Tm. Off.


Package Label - Principal Display Panel - Secura Protective Ointment - Tube (70 G)



Item #59431500


NDC 69740-315-00


Protective 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 Ointment

Net wt. 2.47 oz. (70 g)

DRUG FACTS

ACTIVE INGREDIENT

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?

1 800 876-1261


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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