FDA Label for Secura Personal Skin Care Kit
View Indications, Usage & Precautions
- OTHER
- DIRECTIONS
- OTC - QUESTIONS
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- OTC - KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENTS
- ACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA PERSONAL SKIN CARE KIT
- PACKAGE LABEL - SIDE DISPLAY PANEL - SECURA PERSONAL SKIN CARE KIT
- PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA PERSONAL CLEANSER (236ML)
- PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA PROTECTIVE OINTMENT (70G)
Secura Personal Skin Care 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
#59434300
NDC 69740-343-00
Personal Skin Care 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.
- spray 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 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
Otc - Questions
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.
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
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
- 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.
Otc - Keep Out Of Reach Of Children
- Keep out of reach of children. In case of accidental ingestion, 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, octoxynol-9, sodium citrate, polysorbate 20, propylene glycol, citric acid, diazolidinyl urea, polyquaternium-4, benzyl alcohol, methylparaben, fragrance, disodium EDTA, D&C Red #33
benzyl alcohol, clove oil, o-phenylphenol, tocopheryl acetate, corn oil, retinyl palmitate, cholecalciferol, D&C Green #6
Active Ingredients
Petrolatum 98.789%
Questions Or Comments?
1 800 876-1261
Package Label - Principal Display Panel - Secura Personal Skin Care Kit
#59434300
NDC 69740-343-00
Personal 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
- For treatment and prevention of incontinence-associated dermatitis
- Enriched with Vitamins A, D & E
- Pediatric tested
- CHG compatible
- Enriched with Clove Oil
Skin Protectant
SECURA◊ Protective Ointment
2.47 oz. (70 g)
Smith&Nephew
Secura◊
Personal Skin Care Kit
Package Label - Side Display Panel - Secura Personal Skin Care Kit
#594343000
NDC 69740-343-00
Personal Skin Care Kit
Kit Contains:
Secura◊ Personal Cleanser8 fl. oz. (236 mL)
Secura◊ Protective Ointment
2.47 oz. (70 g)
Smith&Nephew
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
- antimicrobial skin cleanser for the perineum or body
- aids in the removal of urine, feces, or other foreign material
- 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.
- spray cleanser liberally on affected area, then wipe clean
- no rinsing necessary
Smith&Nephew
Secura◊
Personal Cleanser
8 fl oz. (236 mL)
DRUG FACTS
ACTIVE INGREDIENT
Benzethonium chloride 0.13%
PURPOSE
Antimicrobial
USES
WARNINGS
DIRECTIONS
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 69740-315-00
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 (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?
1 800 876-1261
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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