Label: VEGA ORAL CARE RECOVERY CUCUMBER- kit kit
- NDC Code(s): 69685-106-01
- Packager: StellaLife, Inc.
- 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 March 26, 2024
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StellaLife VEGA Oral Care Cucumber Rinse
StellaLife VEGA Oral Care Cucumber Rinse
Cucumber Rinse Active Ingredient
Azadirachta indica 3X
Calendula 3X
Echinacea purpurea 3X
Plantago major 3XPurpose
Active ingredient Purpose Azadirachta indica Antigingivitis, swelling Calendula Antiseptic Echinacea purpurea Antiseptic Plantago major Antiseptic Uses
■ Antimicrobial.
■ Promotes oral health.
■ Hydrates oral cavity.
■ Supports healthy gums.
■ Freshens breath.
Directions
Adults and children over the age of 6 years: Shake well. Use 3/4 tablespoon (10 ml) per application 3 times a day or as recommended by a dental professional. Swish in the mouth for 1-2 minutes and 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.
Keep out of reach of children
■ Keep this and all drugs out of the reach of children and pets. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.
PREGNANCY AND BREAST FEEDING
■ As with any drug, if you are pregnant or nursing a baby, seek the advice of a healthcare professional before using this product.
Other information
■ 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.
Warnings
For your protection, this bottle has an inner seal under the cap. Do not use if tamper evident cap seal is broken or missing.
Stop use
■ Stop use and consult a healthcare professional if you experience irritation or unusual sensitivity, or develop a rash.
Ask doctor
■ If pain, swelling or other related symptoms persist for more than 7 days of use, contact a dental professional.
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Unflavored Spray
Unflavored Spray
Unflavored Spray Active Ingredients
Arnica 3X, 6X, 18X, Calendula 3X, Chamomilla 5X, Echinacea angustifolia 3X, Echinacea purpurea 3X, Hepar sulph calc 8X, Hypericum 10X, lgnatia 30X, Ruta 12X, Silicea 8X, Staphysagria 8X
Unflavored Spray Pregnancy
■ As with any drug, if you are pregnant or nursing a baby, seek the advice of a healthcare professional before using this product.
Purpose
Active Ingredient Purpose Arnica Bruising, swelling Calendula Antiseptic Chamomilla Swelling Echinacea angustifolia Antiseptic Echinacea purpurea Antiseptic Hepar sulph calc Antiseptic Hypericum Bruising, wound healing lgnatia Soothing Ledum palustre Analgesic Ruta Bruising Silicea Analgesic, antiseptic Staphysagria Analgesic, soothing Keep out of reach of children
■ 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.
Warnings
For your protection, this bottle has a full body seal. Do not use if this tamper evident seal is broken or missing.
Directions
Adults and children over 6 years of age: Shake well. Spray 3-4 times per application under the tongue. Repeat 3-4 times per day or as directed by your doctor. Consult a healthcare professional for use in children under 6 years of age.
Stop use
■ Stop use and consult a healthcare professional if you experience irritation or unusual sensitivity, or develop a rash.
Ask dental professional
■ If pain, swelling or other related symptoms persist for more than 7 days of use, contact a dental professional.
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Unflavored Gel
Unflavored Gel
Unflavored Gel Active Ingredients
Arnica 3X, 6X, 18X, Calendula 3X, Chamomilla 5X, Echinacea angustifolia 3X, Echinacea purpurea 3X, Hepar sulph calc 8X, Hypericum 10X, lgnatia 30X, Ruta 12X, Silicea 8X, Staphysagria 8X
Purpose
Active Ingredient Purpose Arnica Bruising, swelling Calendula Antiseptic Chamomilla Swelling Echinacea angustifolia Antiseptic Echinacea purpurea Antiseptic Hepar sulph calc Antiseptic Hypericum Bruising, wound healing lgnatia Soothing Ledum palustre Analgesic Ruta Bruising Silicea Analgesic, antiseptic Staphysagria Analgesic, soothing Uses
Temporarily
- Relieves pain and swelling.
- Promotes healing.
- Reduces bruising.
- Relieves oral ulcers.
- Hydrates oral
Directions
Adults and children over the age of 6 years: Wash hands. Apply to the gum at the surgical or affected area with a cotton swab. Allow gel to dissolve. Do not eat or drink for 20 minutes after application. Apply 4 times per day or as directed by a dental professional. Consult your healthcare professional for use in children under6 years of age.
Keep out of reach of children
■ Keep this and all drugs out of the reach of children and pets. In case of accidental overdose, seek professional assistance or contact a poison control center immediately
Pregnancy
■ As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.
Inactive Ingredients
Allantoin, Hydroxyethylcellulose, Potassium sorbate, Purified water, Sodium benzoate, Sodium metabisulfite, Xylitol.
Do not use ■ Do not use if you have a known allergy or sensitivity to any of the ingredients.
Stop Use ■ Stop use and consult a health professional is you experience irritation or unusual sensitivity, or develop a rash,
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
VEGA ORAL CARE RECOVERY CUCUMBER
kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69685-106 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69685-106-01 1 in 1 BOX; Type 1: Convenience Kit of Co-Package 02/10/2024 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 Part 2 1 Part 3 1 Part 1 of 3 STELLALIFE VEGA ORAL CARE CUCUMBER ADVANCED HEALING FORMULA
azadirachta indica, calendula, echinacea purpurea, plantago major rinseProduct Information Item Code (Source) NDC:69685-123 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA 3 [hp_X] in 1 mL PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR 3 [hp_X] in 1 mL CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER 3 [hp_X] in 1 mL AZADIRACHTA INDICA BARK (UNII: G580B439YI) (AZADIRACHTA INDICA BARK - UNII:G580B439YI) AZADIRACHTA INDICA BARK 3 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) WATER (UNII: 059QF0KO0R) ALLANTOIN (UNII: 344S277G0Z) PROPOLIS WAX (UNII: 6Y8XYV2NOF) XYLITOL (UNII: VCQ006KQ1E) ALCOHOL (UNII: 3K9958V90M) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) CUCUMBER (UNII: YY7C30VXJT) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/12/2024 Part 2 of 3 STELLALIFE VEGA ORAL CARE PAIN AND SWELLING RELIEF
arnica, calendula, chamomilla, echinacea angustifolia, echinacea purpurea, hepar sulph calc, hypericum, lgnatia, ruta, staphysagria sprayProduct Information Item Code (Source) NDC:69685-121 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 5 [hp_X] in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 8 [hp_X] in 1 mL ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA 3 [hp_X] in 1 mL ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA 3 [hp_X] in 1 mL ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 3 [hp_X] in 1 mL DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED 8 [hp_X] in 1 mL CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 3 [hp_X] in 1 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 8 [hp_X] in 1 mL HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 10 [hp_X] in 1 mL LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG 6 [hp_X] in 1 mL RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP 12 [hp_X] in 1 mL STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 30 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) WATER (UNII: 059QF0KO0R) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/12/2024 Part 3 of 3 STELLALIFE VEGA ORAL CARE UNFLAVORED PAIN AND SWELLING RELIEF
arnica, calendula, chamomilla, echinacea angustifolia, echinacea purpurea, hepar sulph calc, hypericum, lgnatia, ledum palustre, ruta, silicea, staphysagria gelProduct Information Item Code (Source) NDC:69685-122 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 5 [hp_X] in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 8 [hp_X] in 1 mL ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA 3 [hp_X] in 1 mL ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA 3 [hp_X] in 1 mL ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 3 [hp_X] in 1 mL DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED 8 [hp_X] in 1 mL CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 3 [hp_X] in 1 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 8 [hp_X] in 1 mL HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 10 [hp_X] in 1 mL LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG 6 [hp_X] in 1 mL RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP 12 [hp_X] in 1 mL STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 30 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM METABISULFITE (UNII: 4VON5FNS3C) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) WATER (UNII: 059QF0KO0R) ALLANTOIN (UNII: 344S277G0Z) XYLITOL (UNII: VCQ006KQ1E) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/12/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/08/2024 Labeler - StellaLife, Inc. (079714251)
