Label: SECURA DIMETHICONE PROTECTANT- dimethicone cream

  • NDC Code(s): 69740-322-00, 69740-322-01
  • Packager: Smith & Nephew Medical Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 16, 2024

If you are a consumer or patient please visit this version.

  • 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

    When using this product

    • do not get into eyes
  • STOP USE

    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

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns
  • KEEP OUT OF REACH OF CHILDREN

    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 69740-322-01

    Dimethicone Protectant

    Skin Protectant

    • Contains 5% Dimethicone
    • For treatment and prevention of incontinence-associated dermatitis
    • Helps prevent and temporarily protect, chafed, chapped, cracked or windburned skin or lips
    • Non-irritating, fragrance-free
    • Pediatric tested
    • CHG Compatible
    • Does not clog briefs

    Smith & Nephew

    Secura

    Dimethicone Protectant

    Made in the USA for Smith & Nephew Medical Ltd, 101 Hessle Road, Hull, HU3 2BN, England

    Certain marks reg'd in U.S. Pat and Tm Off.

    dimeth-3-5g

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

    Item #59432200

    NDC 69740-322-00

    Dimethicone Protectant

    Skin Protectant

    • Contains 5% Dimethicone
    • For treatment and prevention of incontinence-associated dermatitis
    • Helps prevent and temporarily protect chafed, chapped, cracked, or windburned skin or lips
    • Non-irritating, fragrance-free
    • Pediatric tested
    • CHG Compatible
    • Does not clog briefs

    Smith & Nephew

    Secura

    Dimethicone Protectant

    Made in the USA for Smith & Nephew Medical Ltd, 101 Hessle Road, Hull, HU3 2BN, England.

    www.smith-nephew.com

    Trademark of Smith & Nephew.

    Certain marks reg'd U.S. Pat and Tm. Off.

    imadimeth-114g

  • INGREDIENTS AND APPEARANCE
    SECURA DIMETHICONE PROTECTANT 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69740-322
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69740-322-013.5 g in 1 PACKET; Type 0: Not a Combination Product08/01/200504/20/2025
    2NDC:69740-322-00114 g in 1 TUBE; Type 0: Not a Combination Product08/01/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01608/01/2005
    Labeler - Smith & Nephew Medical Ltd (216344051)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American CDMO, LLC080170933manufacture(69740-322)