Label: STELLALIFE VEGA ORAL CARE ORAL HYDRATION MIST- oral hydration mist spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated January 18, 2018

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  • Inactive Ingredients

    Allantoin, Citric acid, Glycerin, Peppermint flavor, Peppermint oil, Polysorbate 20, Potassium sorbate, Propolis, Purified water, Xylitol

  • Directions

    Adults and children over 6 years of age: Shake well. Spray 4 times per application. Repeat as needed or as directed by your doctor. Refrain from eating or drinking for at least 20 minutes after use. Consult your healthcare professional for use in children under 6 years of age.

  • Warnings

    • Do not sue if you have a known allergy or sensitivity to any of the ingredients.
    • Stop use and consult a healthcare professional if you experience irritation or unusual sensitivity, or develop a rash.
    • As with any drug, if you are pregnant or nursing a baby, seek the advice of a healthcare professional before using this product.
    • Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.
    • If pain, swelling or other related symptoms persist for more than 7 days of use, contact a dental professional.
  • Active ingredients Purpose

    Contains 0.55% of each of the following HPUS ingredients:

    Azadirachta indica 1X.........Antigingivitis,

    ............................................swelling

    Calendula 1X......................Antiseptic

    Echinacea purpurea 1X......Antiseptic

    Plantago major 1X..............Antiseptic

  • Questions?

    1-800-828-7265 or info@stellalifehealing.com

  • Other information

    For your protection, this bottle has a full body seal. Do not use if tamper evident seal is broken or missing.

    • Store at room temperature.
    • Keep away from direct heat or sunlight.
    • Because of natural ingredients, color may vary over time.
    • Use within 60 days of opening.
  • Uses (continued)

    • Hydrates oral cavity
    • Freshens breath
    • Antimicrobial
    • Promotes oral health
  • Warnings

    • Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.
  • Drug Facts (continued) Uses

    • Hydrates oral cavity
    • Freshens breath
    • Antimicrobial
    • Promotes oral health
  • StellaLife VEGA Oral Care Oral Hydration Mist

    StellaLife Oral Hydration Mist Box Label

  • INGREDIENTS AND APPEARANCE
    STELLALIFE VEGA ORAL CARE ORAL HYDRATION MIST 
    oral hydration mist spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69685-104
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER1 [hp_X]  in 1 mL
    PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR1 [hp_X]  in 1 mL
    AZADIRACHTA INDICA BARK (UNII: G580B439YI) (AZADIRACHTA INDICA BARK - UNII:G580B439YI) AZADIRACHTA INDICA BARK1 [hp_X]  in 1 mL
    ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA1 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    XYLITOL (UNII: VCQ006KQ1E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BEE PROPOLIS EXTRACT (UNII: 6Y8XYV2NOF)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69685-104-011 in 1 BOX01/18/2018
    130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/18/2018
    Labeler - StellaLife, Inc. (079714251)
    Registrant - HomeoCare Laboratories Inc (088248828)
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