Label: BREAST ESSENCE II- dimethicone, allantoin cream

  • 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 July 29, 2014

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

  • ACTIVE INGREDIENT

    Dimethicone 1%

    Allantoin 2%

  • PURPOSE

    Skin Protectant

  • INDICATIONS & USAGE

    Breast Essence to help skin elasticity and beauty

  • WARNINGS

    For external use only.

  • DO NOT USE

    Do not use on damaged or broken skin.

  • ASK DOCTOR

    Stop use and ask a doctor if rash or irritation, red spots, and swelling occur.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • WHEN USING

    When using this product, keep out of eyes.

  • INSTRUCTIONS FOR USE

    Apply breast essence every morning and evening.

  • INACTIVE INGREDIENT

    Pure water, Butylene glycol, Anemarrhena asphodeloides bunge extract, Propylene glycol, Cetyl alcohol, Glyceryl stearate/PEG-100-Stearate, Betaine, Arbutin, Phytrogen, Sorbitan sesquioleate, Polysorbate 80, Sorbitan stearate, Macadamia ternifolia seed oil, Simmondsia chinensis seed oil, Dipotassium glycyrrhizate, Triethanolamine, 1,2-hexandediol, Adenosine, Carbomer, Tocopheryl acetate, Sodium hyaluronate, Cultured wild ginseng roots extracts, Rose extract, Soybean extract, Portulaca oleracea extract, Perfume

  • PRINCIPAL DISPLAY PANEL

    breast essence

  • DOSAGE & ADMINISTRATION

    Apply appropriate amount of essence every morning and evening.

  • INGREDIENTS AND APPEARANCE
    BREAST ESSENCE II 
    dimethicone, allantoin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69142-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.5 mg  in 50 mL
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN1 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ANEMARRHENA ASPHODELOIDES WHOLE (UNII: OH50MKZ7H3)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETYL STEARATE (UNII: 06RI5UQA7L)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    BETAINE (UNII: 3SCV180C9W)  
    ARBUTIN (UNII: C5INA23HXF)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    JOJOBA OIL (UNII: 724GKU717M)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    Adenosine (UNII: K72T3FS567)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    SOYBEAN SEED OIL (UNII: P6C7NVO1UF)  
    PURSLANE (UNII: M6S840WXG5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69142-001-021 in 1 CARTON07/29/2014
    1NDC:69142-001-0150 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/29/2014
    Labeler - yeojaya (688735127)
    Registrant - yeojaya (688735127)
    Establishment
    NameAddressID/FEIBusiness Operations
    yeojaya688735127manufacture(69142-001)