Label: ROYAL JELLY SCAR BALM- dimethicone cream

  • NDC Code(s): 68828-004-01
  • Packager: Jafra Cosmetics International Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 29, 2023

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  • Active ingredient

    Dimethicone 2%

  • Purpose

    Skin protectant

  • Uses

    Temporarily protects and helps relieve chapped or cracked skin

  • Warning

    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 in 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 right away.

  • Direction

    • apply as needed

  • KEEP OUT OF REACH OF CHILDREN

  • Inactive ingredients

    Water/Aqua, Caprylic/Capric Triglyceride, Aluminum Sucrose Octasulfate, Croton Lechleri Resin Extract, Glycerin, Royal Jelly, Honey/Mel, Withania Somniferia (Winter Cherry) Extract, Nelumbo Nucifera (Lotus) Extract, Polyglyceryl-3 Methylglucose Distearate, C12-15 Alkyl Benzoate, Glyceryl Stearate, Butyrospermum Parkii (Shea Butter) Fruit, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Theobroma Cocoa Seed Butter, Cetyl Alcohol, Rosa Moschata Seed Oil, Beta-Glucan, Saccharomyces Lysate Extract, Tocopheryl Acetate, DMDM Hydantoin, Panthenol, Diazolidinyl Urea, Trisodium EDTA

  • Product label

    image description
  • INGREDIENTS AND APPEARANCE
    ROYAL JELLY SCAR BALM 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SUCRALFATE (UNII: XX73205DH5)  
    CROTON LECHLERI RESIN (UNII: GGG6W25C63)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ROYAL JELLY (UNII: L497I37F0C)  
    HONEY (UNII: Y9H1V576FH)  
    WITHANOLIDE D (UNII: XY366XV8JT)  
    NELUMBO NUCIFERA WHOLE (UNII: 622D93A1R1)  
    POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (UNII: W19EIO0DBE)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ROSA MOSCHATA SEED OIL (UNII: T031ZE559T)  
    YEAST .BETA.-D-GLUCAN (UNII: 44FQ49X6UN)  
    SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-004-011 in 1 CARTON06/15/2022
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01606/15/2022
    Labeler - Jafra Cosmetics International Inc (041676479)
    Registrant - Jafra Cosmetics International Inc (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Distribuidora Comercial Jafra, S.A. de C.V.951612777manufacture(68828-004)
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