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Secura Dimethicone Protectant (Smith & Nephew, Inc.)

Available Formats

Dosage Form Package Information Links
CREAM 3.5 g in 1 PACKET (50484-322-01) Label Information
CREAM 114 g in 1 TUBE (50484-322-00) Label Information

Complete Secura Dimethicone Protectant Information

  • DRUG FACTS


  • ACTIVE INGREDIENTS

    Dimethicone 5%


  • PURPOSE

    Skin protectant


  • USES

    • Helps treat and prevent diaper dermatitis
    • Protects minor skin irritation associated with diaper dermatitis and helps protect from wetness
    • Temporarily protects and helps relieve chapped or cracked skin and lips

  • WARNINGS

    For external use only

    When using this product
    •  do not get into eyes

    Stop use and ask a doctor if
    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

    Do not use on
    • deep or puncture wounds
    • animal bites
    • serious burns

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

  • DIRECTIONS

    • Apply as needed
    • 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, isopropyl palmitate, propylene glycol, cetyl dimethicone copolyol, hexyl laurate, polyglycerol-4 isostearate, sodium chloride, paraffin, hydrogenated castor oil, beeswax, methylparaben, disodium EDTA, propylparaben


  • QUESTION OR COMMENTS?

    1 800 876-1261


  • PRINCIPAL DISPLAY PANEL


    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- TUBE (3.5 g)

    Item #59435000

    NDC 50484-322-01

    Dimethicone Protectant


    Skin Protectant

    • Contains 5% Dimethicone
    • For treatment and prevention of diaper dermatitis associated with exposure to feces or urine
    • Does not clog briefs
    • Non-irritating, fragrance-free
    • Pediatrician tested

    Smith & Nephew

    Securaâ—Š

    Dimethicone Protectant


    Manufactured by:
    Smith & Nephew, Inc., Largo, FL 33773

    Trademark of Smith & Nephew. Reg. U.S. Pat. & Tm. Off.


    Package Display - Tube (3.5g)


    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- TUBE (114 g)

    Item #59432200

    NDC 50484-322-00

    Dimethicone Protectant


    Skin Protectant

    • Contains 5% Dimethicone
    • For treatment and prevention of diaper dermatitis associated with exposure to feces or urine
    • Help prevent and temporarily protect chafied, chapped, cracked, or windburned skin or lips
    • Non-irritating, fragrance-free
    • Does not clog briefs
    • Pediatrician tested

    Smith & Nephew

    Securaâ—Š

    Dimethicone Protectant


    Manufactured by:
    Smith & Nephew, Inc., Largo, FL 33773

    www.smith-nephew.com

    Trademark of Smith & Nephew.

    Reg. U.S. Pat. & Tm. Off.


    Package Display - Tube 114g



  • INGREDIENTS AND APPEARANCE
    SECURA DIMETHICONE PROTECTANT 
    dimethicone cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50484-322
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 50 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50484-322-01 3.5 g in 1.0 PACKET; Type 0: Not a Combination Product 08/01/2005 07/31/2018
    2 NDC:50484-322-00 114 g in 1.0 TUBE; Type 0: Not a Combination Product 08/01/2005 07/31/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 08/01/2005 07/31/2018
    Labeler - Smith & Nephew, Inc. (827731451)
    Establishment
    Name Address ID/FEI Business Operations
    Swiss-American CDMO, LLC 080170933 MANUFACTURE(50484-322)