Label: MAXCLINIC HYALURONIC MESO CHANGE ROLLER- hyaluronic acid patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated March 14, 2017

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  • ACTIVE INGREDIENT

    Active Ingredient: Hyaluronic acid 97.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Lactose

  • PURPOSE

    Purpose: Skin Firming & Moisturizing

  • WARNINGS

    Warnings: For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Directions

    Directions: 1. First place the handle on the roller, then remove the protective cap. 2. Gently roll across the entire face for absorption. For optimal results, start rolling from areas with deep wrinkles (neck, smile lines, forehead). 3. Use for 3~5 minutes until the hyaluronic acid melts into the skin and then the roller becomes blunt. * First apply the ampoule on the face and neck, then use the roller. * Intended for a single use only. Please remove and discard the roller after use. * Once opened, use immediately

  • DOSAGE & ADMINISTRATION

    Dosage & Administration: Use once a week.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    MAXCLINIC HYALURONIC MESO CHANGE  ROLLER
    hyaluronic acid patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69058-600
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYALURONIC ACID (UNII: S270N0TRQY) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONIC ACID67.9 mg  in 70 mg
    Inactive Ingredients
    Ingredient NameStrength
    Lactose (UNII: J2B2A4N98G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69058-600-024 in 1 CARTON12/20/2016
    1NDC:69058-600-0170 mg in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/20/2016
    Labeler - N&B LAB.Co.Ltd (690332858)
    Registrant - N&B LAB.Co.Ltd (690332858)
    Establishment
    NameAddressID/FEIBusiness Operations
    N&B LAB.Co.Ltd690332858manufacture(69058-600)