Label: LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE CICAPLAST DEFENSE B5 SKIN PROTECTANT- glycerin gel

  • NDC Code(s): 49967-586-01, 49967-586-02
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 11, 2023

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  • Active ingredient

    Glycerin 21%

  • Purpose

    Skin protectant

  • Uses

    • temporarily protects and helps relieve chapped or cracked skin
  • Warnings

    For external use only

  • Do not use

    • on deep or puncture wounds
    • animal bites
    • serious burns
  • 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
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply as needed
  • Other information

    ● store at room temperature

  • Inactive ingredients

    water, dimethicone, panthenol, pentylene glycol, c30-45 alkyl dimethicone, polybutene, sodium citrate, PEG/PPG-18/18 dimethicone, citric acid, dimethiconol, polysorbate 20, madecassoside, caprylyl glycol, sodium hyaluronate, zinc gluconate, copper gluconate, manganese gluconate, tocopherol

  • Questions or comments?

    1-888-LRP-LABO  1-888-577-5226

    Monday - Friday (9 a.m. - 5 p.m. EST)

  • PRINCIPAL DISPLAY PANEL

    image of a carton

    image of a carton
  • INGREDIENTS AND APPEARANCE
    LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE CICAPLAST DEFENSE B5 SKIN PROTECTANT 
    glycerin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-586
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    C30-45 ALKYL METHICONE (UNII: NFX970DSI2)  
    POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    MADECASSOSIDE (UNII: CQ2F5O6YIY)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    COPPER GLUCONATE (UNII: RV823G6G67)  
    MANGANESE GLUCONATE (UNII: 9YY2F980SV)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-586-011 in 1 CARTON01/01/2023
    140 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:49967-586-021 in 1 CARTON01/01/2023
    23 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01601/01/2023
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetique Active Production282658798manufacture(49967-586) , pack(49967-586)
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