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
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 30, 2023

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

View All Sections
  • 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

  • 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 finalpart34701/01/2023
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetique Active Production282658798manufacture(49967-586) , pack(49967-586)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!