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
  • 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 16, 2022

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

  • 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 finalpart34706/15/2022
    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)