Label: GEM BEAUTY AMETHYST REJUVENATION CREAM- aloe vera flower 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 November 9, 2009

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  • ACTIVE INGREDIENT

    INGREDIENTS:

    Rosa Hybrid Flower Extract, Aloe Ferox Leaf Extract, Camomilla Recutita Flower Extract, Lavender Extract, Honey, Shea Butter, Jojoba Seed Oil, Apricot Seed Oil, Avocado Oil, Caster Oil, Fruit Oil, Collagen, Silk Amino Acids, Ceramide, Amethyst Powder, Arbutin, Cellulose Gum, Tocopherol, Adenosine, Fragrance

  • WARNINGS

    WARNINGS:

    If any adverse reactions occur such as swelling, itching or skin irritation, stop using and consult a doctor immediately.  Avoid use in wounds or around eyes.  For external use only.

  • WHEN USING

    DIRECTIONS:

    Use morning and evening after cleaning and moisturizing.  For on-the-go use, you can apply an amount of the cream directly to your face and around the neck.

  • STORAGE AND HANDLING

    STORAGE:

    Keep out of reach of children.  Store in a cool place and avoid excessive heat.  Seal tightly for further use.  Do not use if seal under cap is broken or missing.

  • DO NOT USE

    EXPIRATION:

    Do not use if older than eighteen months from manufacture.  It would be best to use within six months once the seal is opened.  The date of manufacture is separately marked.

  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL
  • INGREDIENTS AND APPEARANCE
    GEM BEAUTY AMETHYST REJUVENATION CREAM 
    aloe vera flower cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50030-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALOE VERA FLOWER (UNII: 575DY8C1ER) (ALOE VERA FLOWER - UNII:575DY8C1ER) ALOE VERA FLOWER9.15 mL  in 50 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50030-003-0150 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart310.54512/01/2009
    Labeler - GEMPARK CO LTD (690232116)
    Registrant - GEMPARK CO LTD (690232116)
    Establishment
    NameAddressID/FEIBusiness Operations
    GEMPARK CO LTD690232116manufacture
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