Label: CLEAR QQ- 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 October 23, 2015

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  • ACTIVE INGREDIENT

    Active Ingredient: Sodium Fluoride 0.5%

  • INACTIVE INGREDIENT

    Inactive Ingredients: D-Sorbitol 70%, Allantoin, Sodium Saccharine, Mono Sodium Glutamate, Sodium Benzoate, Allantoin Chlor Hydroxy Aluminium, Amino Capronic Acid, Conc Glycerine, Sodium Bicarbonate, Citric Acid, Butylene Glycol, Purified Water, Centella Asiatica Extract, Scutellaria Baicalensis Root Extract, Polygonum Cuspidatum Root Extract, Glycyrryhiza Glabra (Licorice) Root Extract, Camellia Sinensis Leaf Extract, Rose marinus Officinalis (Rosemary)Leaf Extract, Chamomilla Recutita (Matricaria)Flower Extract, Sodium Carboxy Methyl Cellulose, Ethanol, L- Mentol, Apple mint Flavor

  • PURPOSE

    Purpose: The prevention of dental cavities. The teeth white and strong. Remove bad breath. Anti-plaque.

  • WARNINGS

    Warnings: Keep out of reach of children under 6 years of age. If huge amount is accidentally swallowed get medical help of consult doctor.

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Directions: 1) Adults and children 2 years of age and older: Brush teeth throughly preferably after each meal or at least twice a day or as directed by a dentist or doctor. 2) Children under 6 years: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established. 3) Children under 2 years: Consult a dentist or doctor

  • DOSAGE & ADMINISTRATION

    Directions: 1) Adults and children 2 years of age and older: Brush teeth throughly preferably after each meal or at least twice a day or as directed by a dentist or doctor. 2) Children under 6 years: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established. 3) Children under 2 years: Consult a dentist or doctor

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    CLEAR QQ 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70164-010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.75 g  in 150 g
    Inactive Ingredients
    Ingredient NameStrength
    Allantoin (UNII: 344S277G0Z)  
    Sodium Bicarbonate (UNII: 8MDF5V39QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70164-010-01150 g in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35509/01/2015
    Labeler - YOURMG. CO. LTD (687578133)
    Registrant - YOURMG. CO. LTD (687578133)
    Establishment
    NameAddressID/FEIBusiness Operations
    YOURMG. CO. LTD687578133manufacture(70164-010)
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