FDA Label for Secura Starter Kit
View Indications, Usage & Precautions
- OTHER
- DIRECTIONS
- DRUG FACTS - SECURA MOISTURIZING CLEANSER ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNING
- OTC - KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENTS
- DRUG FACTS - SECURA PROTECTIVE OINTMENT ACTIVE INGREDIENT
- WARNINGS
- QUESTIONS OR COMMENTS?
- PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA STARTER KIT
- PACKAGE LABEL - SIDE DISPLAY PANEL - SECURA STARTER KIT
- PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA MOISTURIZING CLEANSER - BOTTLE (236 ML)
- PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA PROTECTIVE OINTMENT - TUBE (70 G)
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.
Other
#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.
- apply cleanser liberally on the affected area, then wipe clean
- no rinsing necessary
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.
• 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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