Label: STELLALIFE VEGA ORAL CARE COCONUT- risne rinse

  • 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 August 26, 2021

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  • Drug Facts

    Contains 0.25% of each of the following HPUS ingredients:

    Active IngredientsPurpose
    Azadirachta indica 1XAntigingivitis, swelling
    Apis mellifica 12XSoothing, healing
    Calendula 1XAntiseptic
    Echinacea purpurea 1XAntiseptic
    Okoubaka aubrevellei 6XSoothing, healing
    Phosphorous 12XAnaglesic
    Plantago major 1XAntiseptic
    Strontium 30XAnalgesic
    Thuja occidentalis 3XAnalgesic, soothing

  • Uses

    Promotes oral health

    Hydrates oral cavity

    Supports healthy gums

    Freshens breath

  • Usage

    • Antimicrobial
    • Promotes oral health
    • Hydrates oral cavity
    • Supports healthy gums
    • Freshens breath.
  • Warnings

    • Do not use if you have a known allergy or sensitivity to any of the following 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 advise 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 poison control center immediately.
    • If pain, swelling or other related symptoms persist for more than 7 days of use, contact a dental professional.
  • Keep Out of Reach of Children

    Keep this and all drugs out of reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

  • Directions

    Adults and children ovver the age of 6 years: Shake well. Use 3/4 tablespoon (10 ml) per application 3 times a day. Swish in the mouth for 1-2 minutes abnd then spit out. Do not swallow. 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.

  • Other Information

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

    • Store at toom temperature.
    • Keep away from direct heat or sunlight.
    • Because of natural ingredients, color may vary over time.
    • Use within 60 days of opening.
  • Inactive Ingredients

    ALLANTOIN, WATER, XYLITOL, POTASSIUM SORBATE, COCONUT, CITRIC ACID MONOHYDRATE, GLYCERIN

  • PRINCIPAL DISPLAY PANEL

    Rinse Box

  • INGREDIENTS AND APPEARANCE
    STELLALIFE VEGA ORAL CARE COCONUT 
    risne rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69685-113
    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
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA12 [hp_X]  in 1 mL
    AZADIRACHTA INDICA BARK (UNII: G580B439YI) (AZADIRACHTA INDICA BARK - UNII:G580B439YI) AZADIRACHTA INDICA BARK1 [hp_X]  in 1 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG3 [hp_X]  in 1 mL
    ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA1 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
    PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR1 [hp_X]  in 1 mL
    STRONTIUM (UNII: YZS2RPE8LE) (STRONTIUM - UNII:YZS2RPE8LE) STRONTIUM30 [hp_X]  in 1 mL
    OKOUBAKA AUBREVILLEI BARK (UNII: MK2074187Z) (OKOUBAKA AUBREVILLEI BARK - UNII:MK2074187Z) OKOUBAKA AUBREVILLEI BARK6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    COCONUT (UNII: 3RT3536DHY)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALLANTOIN (UNII: 344S277G0Z)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorCOCONUTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69685-113-161 in 1 BOX01/08/2021
    1473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/08/2021
    Labeler - StellaLife, Inc. (079714251)
    Registrant - Homeocare Laboratories, Inc. (088248828)
    Establishment
    NameAddressID/FEIBusiness Operations
    Homeocare Laboratories Inc088248828manufacture(69685-113)
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