UNIWELL 8575 SALT (ROSIN) POWDER, DENTIFRICE [SOLM CO., LTD.]

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  • UNIWELL 8575 SALT (ROSIN) POWDER, DENTIFRICE [SOLM CO., LTD.]

UNIWELL 8575 SALT (ROSIN) POWDER, DENTIFRICE [SOLM CO., LTD.]
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NDC 70706-1003-1
Set ID 32b2f1a2-6307-74f8-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager SOLM Co., Ltd.
Generic Name
Product Class
Product Number
Application Number
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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)
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