Label: AIRLINE DENTAL PRODUCTS WITH CREST AND MANUAL TOOTHBRUSH- sodium fluoride kit

  • NDC Code(s): 37000-020-01, 72135-005-02
  • Packager: Luoding Quality Amenities Supply Limited
  • 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 October 18, 2021

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredients

    Sodium fluride 0.243% (0.15% w/v fluoride ion)

    Purpose

    Anticavity toothpaste

  • Use

    helps protect against cavities

  • Warnings

    Keep out of the 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 yrs. & older: brush teeth thoroughly after meals of at least twice a day or use as directed by a dentist
    • do not swallow
    • to minimize swallowing use a pea-sized amount in children under 6 
    • supervise children's brushing until good habits are established
    • children under 2 yrs.: ask a dentist
  • Inactive ingredients

    sorbitol, water, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, sodium hydroxide, alcohol (0.7%), xanthan gum, sodium saccharin, glycerin, carbomer, cellulose gum, polysorbate 80, sodium benzoate, cetylpyridinium chloride, benzoic acid, titanium dioxide, blue 1, yellow 5

  • Questions ?

    1-800-492-7378

  • Package Labeling:

    Outer PackageInner Package

  • INGREDIENTS AND APPEARANCE
    AIRLINE DENTAL PRODUCTS WITH CREST AND MANUAL TOOTHBRUSH 
    sodium fluoride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72135-005
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72135-005-021 in 1 KIT11/14/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 24 g
    Part 1 of 1
    CREST COMPLETE MULTI-BENEFIT  WHITENING PLUS SCOPE
    sodium fluoride paste, dentifrice
    Product Information
    Item Code (Source)NDC:37000-020
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALCOHOL (UNII: 3K9958V90M)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-020-0124 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35511/14/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35511/14/2018
    Labeler - Luoding Quality Amenities Supply Limited (528126807)