FDA Label for Secura Epc Skin Care Starter Kit
View Indications, Usage & Precautions
- OTHER
- DIRECTIONS
- DRUG FACTS - SECURA◊ MOISTURIZING CLEANSER ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- OTC - KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- DRUG FACTS - SECURA◊ EXTRA PROTECTIVE CREAM ACTIVE INGREDIENT
- OTHER INFORMATION
- PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA EPC SKIN CARE STARTER KIT
- PACKAGE LABEL - SIDE DISPLAY PANEL - SECURA EPC SKIN CARE STARTER KIT
- PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA EXTRA PROTECTIVE CREAM - TUBE (92 G)
- PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA MOISTURIZING CLEANSER - BOTTLE (118 ML)
Secura Epc Skin Care 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
#59434100
NDC 69740-341-00
EPC Skin Care Starter Kit
Good skin care can help prevent breakdown.
Directions
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 unrine 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. and Tm. Off.
• apply 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 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 and feces, or other foreign material
• 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. 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
petrolatum, karaya gum, cetearyl alcohol, methyl glucose dioleate, mineral oil, cellulose gum, water, methylparaben, tocopheryl acetate, diazolidinyl urea, benzethonium chloride, butylparaben
Questions Or Comments?
1 800 876-1261
Drug Facts - Secura◊ Extra Protective Cream Active Ingredient
Zinc Oxide 30.6%
Other Information
Store at controlled room temperature 59˚F-86˚F (15˚C-30˚C)
Package Label - Principal Display Panel - Secura Epc Skin Care Starter Kit
#59434100
NDC 69740-341-00
EPC Skin Care Starter Kit
Kit contains:
Antimicrobial Skin Cleanser
Secura◊ Moisturizing Cleanser
4 fl. oz. (118 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◊ Extra Protective Cream
3.25 oz. (92 g)
• For treatment and prevention of incontinence-associated dermatitis
• For use on denuded skin associated with exposure to feces or urine
• Adheres to macerated skin
• Pediatric tested
• CHG compatible
Smith&Nephew
Secura◊
EPC Skin Care Starter Kit
Package Label - Side Display Panel - Secura Epc Skin Care Starter Kit
#59434100
NDC 69740-341-00
EPC Skin Care Starter Kit
Kit contains:
Secura◊ Moisturizing Cleanser
4 fl. oz. (118 mL)
Secura◊ Extra Protective Cream
3.25 oz. (92 g)
Smith&Nephew
Secura◊
EPC Skin Care Starter Kit
Package Label - Principal Display Panel - Secura Extra Protective Cream - Tube (92 G)
Item #59432400
NDC 69740-324-00
Extra Protective Cream
Skin Protectant
• For treatment and prevention of incontinence-associated dermatitis
• For use on denuded skin associated with exposure to feces or urine
• Adheres to macerated skin
• Pediatric tested
• CHG compatible
Smith & Nephew
Secura◊
Extra Protective Cream
Net wt. 3.25 oz. (92 g)
DRUG FACTS
ACTIVE INGREDIENT
Zinc Oxide 30.6%
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 cream liberally as often as necessary with each diaper change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces or urine may be prolonged
OTHER INFORMATION
Store at controlled room temperature 59˚F-86˚F (15˚C-30˚C)
INACTIVE INGREDIENTS
petrolatum, karaya gum, cetearyl alcohol, methyl glucose dioleate, mineral oil, cellulose gum, water, methylparaben, tocopheryl acetate, diazolidinyl urea, benzethonium chloride, butylparaben
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.
Package Label - Principal Display Panel - Secura Moisturizing Cleanser - Bottle (118 Ml)
Item #59430800
NDC 69740-308-00
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
4 fl. oz. (118 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 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 the USA for Smith & Nephew 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.
* Please review the disclaimer below.