Label: AMAR- sodium fluoride 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 22, 2009

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active ingredient

    Sodium Fluoride 0.22% (0.1 w/v fluoride ion)

  • Purpose

    Anticavity

  • Use

    helps protect against cavities.

  • Warning

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

    If more than used for brushing is accidently swallowed, get medical help or contact a poison control center right away.

  • Directions

    Adults and children 6 years of age and olderBrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physician.
    Children 2 to 6 yearsUse only a pea sized amount and supervise child's brushing and rinsing to minimize swallowing.
    Children under 2 yearsAsk a dentist or physician.
  • Inactive Ingredients

    Sorbitol, Titanium Dioxide, Treated Water, Sodium Lauryl Sulphate, Silica, Flavor, Sodium Saccharine, Sodium Methyl Paraben, Sodium Propyl Paraben, Sodium Carboxymethylcellulose (SCMC).

  • SPL UNCLASSIFIED SECTION

    Distributed by: Amar Remedies Inc.

  • PRINCIPAL DISPLAY PANEL - 181 g Carton

    NEW

    Anticavity Fluoride Toothpaste

    Amar

    FREE Toothbrush

    ADVANCED
    WHITENING
    TOOTHPASTE

    Anticavity Fluoride Toothpaste

    NET WT 6.4 oz (181g)

    PRINCIPAL DISPLAY PANEL - 181 g Carton
  • INGREDIENTS AND APPEARANCE
    AMAR   ADVANCED WHITENING
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41499-107
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride0.22 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41499-107-01181 g in 1 TUBE
    2NDC:41499-107-02181 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35512/01/2009
    Labeler - Amar Remedies Limited - Mumbai (677141751)
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