Label: LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE CICAPLAST BALM B5 THERAPEUTIC MULTIPURPOSE- dimethicone cream

  • NDC Code(s): 69625-743-01, 69625-743-02, 69625-743-03, 69625-743-04
  • Packager: Cosmetique Active Production
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 11, 2023

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  • Active ingredient

    Dimethicone 1%

  • Purpose

    Skin protectant

  • Uses

    • temporarily protects and helps relieve chafed, chapped or cracked skin
    • helps protect from the drying effects of wind and cold weather
    • helps treat and prevent diaper rash
    • protects chafed skin due to diaper rash and helps seal out wetness
  • 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

    For diaper rash:

    • change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry
    • apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
  • Other information

    ● store at room temperature

  • Inactive ingredients

    water, hydrogenated polyisobutene, glycerin, butyrospermum parkii (shea) butter, panthenol, aluminum starch octenylsuccinate, butylene glycol, propanediol, cetyl PEG/PPG-10/1 dimethicone, trihydroxystearin, zinc gluconate, madecassoside, manganese gluconate, silica, aluminum hydroxide, magnesium sulfate, disodium EDTA, copper gluconate, citric acid, acetylated glycol stearate, polyglyceryl-4 isostearate, tocopherol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, sodium benzoate, phenoxyethanol, chlorhexidine digluconate, titanium dioxide

  • 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 BALM B5 THERAPEUTIC MULTIPURPOSE 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69625-743
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    MADECASSOSIDE (UNII: CQ2F5O6YIY)  
    MANGANESE GLUCONATE (UNII: 9YY2F980SV)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    COPPER GLUCONATE (UNII: RV823G6G67)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ACETYLATED GLYCOL STEARATE (UNII: K71M6R9N7E)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69625-743-011 in 1 CARTON03/15/2021
    140 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69625-743-021 in 1 CARTON03/15/2021
    23 mL in 1 TUBE; Type 0: Not a Combination Product
    3NDC:69625-743-031 mL in 1 PACKET; Type 0: Not a Combination Product03/15/2021
    4NDC:69625-743-041 in 1 CARTON01/01/2023
    4100 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01603/15/2021
    Labeler - Cosmetique Active Production (282658798)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetique Active Production282658798manufacture(69625-743)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'OREAL USA PRODUCTS, INC.624244349pack(69625-743)
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