Label: DR DEEP DEEP FRESH- glycerin 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 August 12, 2016

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

  • ACTIVE INGREDIENT

    Active Ingredient: Silicon Dioxide 4%, Glycerin 6.4%

  • INDICATIONS & USAGE

    Squeeze appropriate amount of toothpaste onto your toothbrush and gently brush your teeth with a short, vertical or circular motion

  • DOSAGE & ADMINISTRATION

    For brushing teeth

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings:

    - For external use only

    - Do not use on wounds or damaged skin

  • WHEN USING

    When using this product, do not use other than directed

  • STOP USE

    Stop use if allergic reaction or irritation occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    - If swallowed, get medical help or contact a Poison Control Center immediately

  • STORAGE AND HANDLING

    Storage: Keep in a dry and cool place

  • INACTIVE INGREDIENT

    Inactive Ingredients: Aluminum Chlorohydroxy Allantoinate, Aminocaproic Acid, D-Sorbitol Solution, Polyethylene Glycol 4000, stevgiol Glycoside, Xylitol, Citrus Paradisi (Grapefruit) Seed Extract, Camellia Sinensis Leaf Extract, Sodium Carboxymethyl Cellulose, Cacamidopropyl Betaine, L-Menthol, Mentha Piperita (Peppermint) Oil, Aqua

  • PRINCIPAL DISPLAY PANEL

    Box Label

  • INGREDIENTS AND APPEARANCE
    DR DEEP DEEP FRESH 
    glycerin paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76015-110
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN7.68 g  in 120 g
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 4.8 g  in 120 g
    ALCLOXA (UNII: 18B8O9DQA2)  
    AMINOCAPROIC ACID (UNII: U6F3787206)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    XYLITOL (UNII: VCQ006KQ1E)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    MENTHA PIPERITA (UNII: 79M2M2UDA9)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76015-110-011 in 1 PACKAGE08/12/2016
    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 finalpart34708/12/2016
    Labeler - MineralHouse Corporation (557802539)
    Registrant - MineralHouse Corporation (557802539)
    Establishment
    NameAddressID/FEIBusiness Operations
    MineralHouse Corporation557802539relabel(76015-110) , repack(76015-110)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sangleaf Pharm., Co. Ltd.689847343manufacture(76015-110)