Label: SLOW CORPORATION- toothpaste, sodium monofluorophosphate paste

  • 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 January 13, 2022

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  • ACTIVE INGREDIENT

    Sodium Monofluorophosphate 0.76%

  • Use

    Helps protect against cavities

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Directions:

    Adult 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.

  • WARNINGS

    If more than used for brushing is accidentally swalloed, get medical help or contact a Poison Control Center right away.

  • INACTIVE INGREDIENT

    Sorbitol, purified water, Hydrated silica, Glycerin, Xylitol, Xanthan gum, Sodium Cocoyl Glutamate, Stevia Rebaudiana Extract, Cocos Nucifera (Coconut) Oil, Cellulose Gum, Menthol, Mentha Spicata Herb Oil, Rosmarinus Offiicinalis (Rosemary) Extract, Centella Asiatica Extract, Scutellaria Baicalensis Root Extract, Camellia Sinensis Leaf Extract, Calendula Officinalis Flower Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla Recutita (Matricaria) Extract, Charcoal Powder, Cannabis Sativa (Hemp) Seed Oil

  • DOSAGE & ADMINISTRATION

    Paste pea size of toothpaste on the tooth brush

  • PRINCIPAL DISPLAY PANEL

    250g; NDC 81111-100-01

    Toothpaste_PDPToothpaste_DF

  • INGREDIENTS AND APPEARANCE
    SLOW CORPORATION 
    toothpaste, sodium monofluorophosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81111-100
    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
    WATER (UNII: 059QF0KO0R)  
    STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    XYLITOL (UNII: VCQ006KQ1E)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 1200 MPA.S AT 1%) (UNII: 4J4P6L645M)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MENTHOL (UNII: L7T10EIP3A)  
    SORBITOL (UNII: 506T60A25R)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81111-100-01250 g in 1 BOTTLE; Type 0: Not a Combination Product11/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35511/20/2020
    Labeler - Integrity12 Inc (695586794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sangleaf Pharm Co., Ltd.689847343manufacture(81111-100)
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