Label: GREENCO paste, dentifrice

  • 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 December 6, 2017

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  • Active ingredient

    Sodium Fluoride 0.24%

  • Purpose

    Anticavity

  • Uses

    Aids in the prevention of dental cavities.

  • Warnings

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits to minimize swallowing. Supervise children as necessary until capable of using without supervision.
    • Children under 2 years of age: consult a dentist or doctor.
  • Other informaiton

    For your protection, this tube has a foil seal under the cap.

  • Inactive ingredients

    Sorbitol, Hydrated Silica, Water, Glycerin, PEG 12, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Benzoate, Disodium Phosphate, Sodium Saccharin, FD&C Blue #1

  • Principal Display Panel

    Fresh Mint Tartar Control

    Greenco

    NET WT. 1.5oz. (43grams) Fluoride Toothpaste

    Greenco_mint_paste

    Greenco_mint_toothpaste

  • INGREDIENTS AND APPEARANCE
    GREENCO 
    greenco paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63372-0596
    Route of AdministrationDENTAL, ORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENTONITE (UNII: K1BPI94O04)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SORBITOL (UNII: 506T60A25R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63372-0596-285 g in 1 TUBE; Type 0: Not a Combination Product10/15/1997
    2NDC:63372-0596-143 g in 1 TUBE; Type 0: Not a Combination Product10/15/1997
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35510/15/1997
    Labeler - Greenco Industries, Inc. (091789941)
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