Label: ROYAL JELLY BODY HAND AND CUTICLE COMPLEX- dimethicone cream

  • NDC Code(s): 68828-445-01
  • Packager: Jafra Cosmetics International
  • 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 September 2, 2021

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  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Dimethicone 1.5% Skin Protectant

  • PURPOSE

    Use

    • Helps prevent and temporarily protects chapped or cracked skin
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center righy away.

  • INDICATIONS & USAGE

    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

  • WARNINGS

    Warnings

    For external use only

    when using this product

    • do not get into eyes

    Do not use on

    • deep puncture wounds
    • animal bites
    • serious burns
  • DOSAGE & ADMINISTRATION

    Directions

    • Apply as needed
  • INACTIVE INGREDIENT

    Inactive ingredients

    Water/Aqua, Prunus Armeniaca (Apricot) Kernel Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Hydrogenated Vegetable Oil/ Olus Oil, Cetearyl Alcohol, Ceteareth-20, C12-15 Alkyl Benzoate, Glycerin, Sodium PCA, Butyrospermum Parkii (Shea Butter), Bis-Diglyceryl Polyacyladipate-2, Cetyl Alcohol, Stearyl Stearate, Myristyl Myristate, Royal Jelly Powder, Lecithin, Dipropylene Glycol, Royal Jelly, Tetrapeptide-45, Hydrogenated Lecithin, Garcinia Indica Seed Butter, Theobroma Cocoa Butter, Chamomilla Recutita (Matricaria) Extract, Morus Alba Extract, Lonicera Caprifolium (Honeysuckle) Flower extract, Ipomoea Digitata (Fingerleaf Morning Glory) Extract, Withania Somnifera (Winter Cherry) Extract, Vigna Radiata (Mung Bean) Extract, DMDM Hydantoin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Fragrance/Parfum, Allantoin, Panthenol, Tocopherol, Trisodium EDTA, Phenoxyethanol, Hexylene Glycol, Caprylyl Glycol, Potassium Sorbate, PEG-4 Laurate, Iodopropynyl Butylcarbamate, PEG-4, PEG-4 Dilaurate, Phenethyl Alcohol, Ethylhexylglycerin, Maltodextrin

  • PRINCIPAL DISPLAY PANEL

    Jafra Royal

    Royal Jelly

    Body

    Hand and cuticle complex

    75 ml 2.5 FL OZ (US)

    tube Hand and Cuticle complex

    carton Hand and cuticle complex

  • INGREDIENTS AND APPEARANCE
    ROYAL JELLY BODY HAND AND CUTICLE COMPLEX 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-445
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MUNG BEAN (UNII: 1LIB31N73G)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ROYAL JELLY (UNII: L497I37F0C)  
    GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    STEARYL STEARATE (UNII: 5WX2EGD0DK)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ)  
    LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PEG-4 DILAURATE (UNII: KCR71CW036)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-445-0175 mL in 1 CARTON; Type 0: Not a Combination Product09/02/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/02/2021
    Labeler - Jafra Cosmetics International (041676479)
    Registrant - Jafra Manufacturing, S.A. de C.V. (814732061)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jafra Manufacturing, S.A. de C.V.814732061manufacture(68828-445)
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