Label: PINE SALT- 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 August 19, 2011

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  • Active ingredient

    sodium fluoride 0.22%
  • Purpose

    Anticavity
  • Uses

    helps protect against cavities
  • Warnings

    Enter section text here

    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 physician
    Children 2 to 6 years
    		use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).
    Children under 2 years
    		ask a dentist or physician
  • Inactive ingredients

    di water, sorbitol, hydrated silica, sodium methyl cocoyl taurate, peg-32, sodium lauryl sulfate, baked sodium chloride, flavor, cellulose gum, songyum capsule, sodium saccharin, disodium phosphate, menthol capsule, methyl paraben, pine extract, tranexamic acid, yellow no.10, blue no.1
  • Package label

    Pine Salt Toothpasteimage of toothpaste carton

  • INGREDIENTS AND APPEARANCE
    PINE SALT 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0043
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.2 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    PEG-32 STEARATE (UNII: 33GX5WQC0M)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PINUS STROBUS BARK (UNII: 8PJ4761097)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0043-61 in 1 BOX
    1170 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35508/22/2011
    Labeler - Kareway Product, Inc. (121840057)
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