FDA Label for Secura Two Step Kit

#59434400 Ndc 69740-344-00

Two-Step Kit

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.

• apply cleanser liberally on 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 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

Active Ingredients

Benzethonium chloride 0.13%

Zinc oxide 10%

Purpose

Antimicrobial

Skin protectant

Uses

• antimicrobial skin cleanser for the perineum or body
• aids in the removal of urine and 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

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

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison 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

water, petrolatum, cetearyl alcohol, PEG-40 castor 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?

1 800 876-1261

Package Label.Principal Display Panel

PACKAGE LABEL (Front)

#59434400
NDC 69740-344-00

Two-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 Cleanser

8 fl. oz. (236 mL)

SECURA◊ Protective Cream

2.75 oz. (78 g)

smith&nephew

SECURA◊

Two-Step Kit

Two Step Kit Front Label - two step kit

Package Label - Secura Moisturizing Cleanser

Item #59430900
NDC 69740-309-00

Moisturizing
Cleanser

Antimicrobial 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 Cleanser}

8 fl. oz. (236mL)


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 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.

Cleanser Label 236 mL - 236ml moisturizing cleanser

Package Display Panel - Secura Protective Cream

Item #59431200
NDC 69740-312-00

Protective 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 Cream}

New 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.

Protective Cream 78 g - 78g protective cream