Label: REMBRANDT- sodium monofluorophosphate 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 9, 2019

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient: Sodium Monofluorophosphate 0.76%

  • PURPOSE

    Purpose: Anticavity

  • INDICATIONS & USAGE

    Use: Aids in the prevention of dental cavities.

  • WARNINGS

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

  • DOSAGE & ADMINISTRATION

    Directions: Adults and children 2 years of age & older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. Do not swallow. Children under 6 years of age: Use a pea-sized amount and instruct 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. Do not swallow.

  • INACTIVE INGREDIENT

    Inactive ingredients: CALCIUM CARBONATE, SORBITOL, TREATED WATER, SILICA, SODIUM LAURYL SULPHATE, FLAVOR, SODIUM CARBOXY METHYL CELLULOSE, SODIUM SILICATE, TETRA SODIUM PYROPHOSPHATE, BENZYL ALCOHOL, SODIUM SACCHARIN, PROPYLPARABEN.

  • SPL UNCLASSIFIED SECTION

    LICENSED BY RANIR, LLC. ALL RIGHTS RESERVED.      MADE IN INDIA
    DIST. BY: ASHTEL STUDIOS, INC., ONTARIO, CA 91761 • COMMENTS OR QUESTIONS?
    1-877-274-8358 TOLL FREE IN U.S.A. • 1-909-434-0911 INTERNATIONAL

    Q

    QUICK CLEAN®

    TOOTHPASTE WITH FLUORIDE

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    REMBRANDT 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70108-031
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SODIUM SILICATE (UNII: IJF18F77L3)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70108-031-0110 g in 1 TUBE; Type 0: Not a Combination Product12/15/2019
    2NDC:70108-031-0220 g in 1 TUBE; Type 0: Not a Combination Product12/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35512/15/2019
    Labeler - Ashtel Studios, Inc (148689180)
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