Label: MORNING FRESH- sodium fluoride paste

  • 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 15, 2017

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  • Active Ingredient

    Sodium Fluoride 0.22 %

  • Purpose: Anticavity

    Use

    • Aids in the prevention of dental cavities.
  • Inactive Ingredient

    Calcium carbonate, Carboxymethycellulose sodium, Flavour, Hydrated silica,Potassium nitrate,  Purified water, Saccharin sodium, Sodium benzoate, Sodium lauryl sulfate, Sorbitol

  • Dosage and Administration

    Directions:

    • Adults and children 2 years and older Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician.
    • Children under 6 years To minimize swallowing, use a pea sized amount and supervise brushing until good habits are established.
    • Children under 2 years Ask a dentist or physician.
  • Indications and Usage

    • The prevention of dental cavities.
  • Warnings

    • If you accidentally swallow more than used for brushing, seek professional assistance or contact a Poison Control Center immediately.
  • Keep out of reach of children.

    Keep out of reach of children under 6 years of age.

  • Principal Display Panel

    Patcos Toothpaste

    Patcos Toothpaste 1.jpg

    Patcos Toothpaste

  • INGREDIENTS AND APPEARANCE
    MORNING FRESH 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68121-174
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.2 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POTASSIUM NITRATE (UNII: RU45X2JN0Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68121-174-0143 g in 1 TUBE; Type 0: Not a Combination Product05/14/2014
    2NDC:68121-174-0278 g in 1 TUBE; Type 0: Not a Combination Product05/14/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35505/14/2014
    Labeler - Patcos Cosmetics (India) Private Limited (916169451)
    Establishment
    NameAddressID/FEIBusiness Operations
    Patcos Cosmetics (India) Private Limited675973979manufacture(68121-174)
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