Label: DR. GINGIVA- fluoride toothpaste with natural herbs paste

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 9, 2020

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

  • Drug Facts

  • Active ingredients

    Stannous fluoride 0.454 % (0.15 % w/v fluoride ion)

  • Purposes

    Anticavity
    Antigingivitis

  • Uses

    • helps control bleeding gums and gingivitis. ▪ aids in the prevention of dental cavities.
    • aids in the prevention of dental cavities.
    • helps interfere with harmful effects of plaque associated with gingivitis.
  • Warnings

    • this product is not intended to control major bleeding. Ask a dentist or doctor if you have major bleeding in mouth.
    • do not use if irritation occurs.
  • ASK DOCTOR

    Stop use and ask a dentist if

    • gingivitis, bleeding, or redness persists for more than 2 weeks.
    • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
  • KEEP OUT OF REACH OF CHILDREN

    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 doctor.
    • Keep toothpaste in mouth for two to three minutes. Spit out and rinse with water.
    • instruct children under 6 years of age 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: ask a dentist or doctor.
  • Other Information

    • this product may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by a dentist.
    • this toothpaste contains natural herbs for maintaining oral health and nourishing gums. It may be used regularly everyday for oral care.
    • green color results from natural chlorophyllin copper complex, and may turn darker over time.
  • Inactive ingredients

    sorbitol, hydrated silica, water, PEG-8, sodium lauroyl sarcosinate, aroma, cellulose gum, zanthoxylum nitidum extract, clinopodium chinense extract, chlorophyllin-copper complex, chondrus crispus powder, titanium dioxide, ethyl menthane carboxamide, sodium saccharin, trisodium phosphate, sodium bicarbonate, benzyl alcohol, sodium chloride.

  • PRINCIPAL DISPLAY PANEL

    DUAL-PURPOSE FOR MORE EFFECTIVE CARE

    + Stannous Fluoride Controls Gum Bleeding

    + Natural Herbs Maintain Healthy Gums and Teeth

    Refeshing Spearmint Flavor

    NDC 71775-050-42

    NET WT. 4.25 OZ (120g)

    OTC with Herbs

    INTRODUCING A NEW CONCEPT

    that integrates the proven power of conventional fluoride toothpaste with natural Chinese herbs for superior oral care. Dr. Gingiva combines stannous fluoride, which controls gum bleeding, removes plaque, and prevents gingivitis and dental cavities, with natural Chinese herbs to maintain healthy teeth and gums. This dual-purpose formula is more effective in stopping bleeding and supporting oral health.


    Designed and Distributed by:

    Bad Students Inc

    Product of China

    PDP

  • PRINCIPAL DISPLAY PANEL

    DR. GINGIVA

    Anti-Gingivitis + Anti-Plaque + Anti-Cavity

    CONTROLS GUM BLEEDING

    Fluoride Toothpaste with Natural Herbs

  • INGREDIENTS AND APPEARANCE
    DR. GINGIVA 
    fluoride toothpaste with natural herbs paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71775-050
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    ZANTHOXYLUM NITIDUM ROOT (UNII: L2CQZ81759)  
    CLINOPODIUM CHINENSE WHOLE (UNII: 29350ODC51)  
    SODIUM COPPER CHLOROPHYLLIN (UNII: 1D276TYV9O)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorSPEARMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71775-050-421 in 1 CARTON06/01/2018
    1120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/01/2018
    Labeler - LIUZHOU LMZ CO., LTD. (654623156)
    Registrant - Bad Students Inc (105569266)
    Establishment
    NameAddressID/FEIBusiness Operations
    LIUZHOU LMZ CO., LTD.654623156manufacture(71775-050)