Label: UNIWELL 8575 SALT- rosin powder, dentifrice

  • 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 December 22, 2019

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  • ACTIVE INGREDIENT

    Rosin

  • INACTIVE INGREDIENT

    Sodium chloride

  • PURPOSE

    for dental care

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    use when is needed

  • WARNINGS

    - do not swallow when using this product

    - if more than used for rinsing is accidentally swallowed, get medical helps or contact a poison control center right away

  • DOSAGE & ADMINISTRATION

    Hold 1 grams in mouth for 1~2 minutes then rinse out with water

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    UNIWELL 8575 SALT 
    rosin powder, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70706-1003
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ROSIN (UNII: 88S87KL877) (ROSIN - UNII:88S87KL877) ROSIN0.332   in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70706-1003-175 g in 1 PACKAGE; Type 0: Not a Combination Product05/12/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/12/2016
    Labeler - SOLM Co., Ltd. (689847034)
    Registrant - SOLM Co., Ltd. (689847034)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOLM Co., Ltd.689847034manufacture(70706-1003)