Label: STELLALIFE VEGA ORAL CARE GEL- gel gel
STELLALIFE VEGA ORAL CARE RECOVERY- kit kit
STELLALIFE VEGA ORAL CARE- spray spray
- NDC Code(s): 69685-111-01, 69685-112-01, 69685-115-01
- 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 January 12, 2024
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StellaLife VEGA Oral Care Spray
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 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 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 over 6 years of age: Shake well. Spray 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.
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 room temperature.
Keep away from direct heat or sunlight.
Because of natural ingredients, color may vary over time.
Use within 60 days of opening.Drug Facts
Contains 7.14% of each of the following HPUS ingredients:
Active Ingredients Purpose Arnica 3X, 6X, 18X
Bruising, swelling
Calendula 3X Antiseptic Chamomilla 5X Swelling Echinacea angustifolia 3X
Antiseptic Echinacea purpurea 3X Antiseptic Hepar sulph calc 8X
Antiseptic Hypericum 10X
Bruising, would healing
Ignata 30X
Soothing Ledum palustre 6X
Analgesic Ruta 12X
Bruising Silicea 8X
Analgesic, antiseptic Staphysagria 8X
Analgesic, soothing -
StellaLife VEGA Oral Care Gel
Drug Facts
Contains 0.0714% of each of the following HPUS ingredients:
Active Ingredients Purpose Arnica 3X, 6X, 18X
Bruising, swelling Calendula 3X
Antiseptic Chamomilla 5X
Swelling Echinacea angustifolia 3X
Antiseptic Echinacea purpurea 3X
Antiseptic Hepar sulph calc 8X
Antiseptic Hypericum 10X
Bruising, would healing Ignata 30X
Soothing Ledum palustre 6X
Analgesic Ruta 12X
Bruising Silicea 8X
Analgesic, antiseptic Staphysagria 8X
Analgesic, soothing Usage
Temporarily
- Relieves pain and swelling.
- Promotes healing.
- Reduces bruising.
- Relieves oral ulcers.
- Hydrates oral cavity.
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 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 under 6 years of age.
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StellaLife VEGA Oral Care Rinse (Peppermint)
Drug Facts
Contains 0.55% of each of the following HPUS ingredients:
Active Ingredients Purpose Azadirachta Indica 1X
Antiginivitis, swelling Calendula 1X
Antiseptic Echinacea Purpurea 1X
Antiseptic Plantago Major 1X
Antiseptic 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 over 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 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.
- StellaLife VEGA Oral Care Recovery Kit Display
- StellaLife VEGA Oral Care Gel Display
- StellaLife VEGA Oral Care Spray Display
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INGREDIENTS AND APPEARANCE
STELLALIFE VEGA ORAL CARE GEL
gel gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69685-112 Route of Administration DENTAL, TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG 6 [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 ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA 3 [hp_X] in 1 mL HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 10 [hp_X] in 1 mL STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 30 [hp_X] in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 8 [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 ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 18 [hp_X] in 1 mL MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 5 [hp_X] in 1 mL ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA 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 CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 8 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength PEPPERMINT OIL (UNII: AV092KU4JH) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) XYLITOL (UNII: VCQ006KQ1E) ALLANTOIN (UNII: 344S277G0Z) Product Characteristics Color yellow Score Shape Size Flavor PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69685-112-01 1 in 1 BOX 01/08/2021 1 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/08/2021 STELLALIFE VEGA ORAL CARE RECOVERY
kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69685-115 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69685-115-01 1 in 1 BOX; Type 1: Convenience Kit of Co-Package 01/08/2021 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
spray sprayProduct Information Item Code (Source) NDC:69685-111 Route of Administration SUBLINGUAL, DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG 6 [hp_X] in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 8 [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 HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 10 [hp_X] in 1 mL STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 30 [hp_X] in 1 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 8 [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 ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 18 [hp_X] in 1 mL MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 5 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/08/2021 Part 2 of 3 STELLALIFE VEGA ORAL CARE GEL
gel gelProduct Information Item Code (Source) NDC:69685-112 Route of Administration DENTAL, TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 8 [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 ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 18 [hp_X] in 1 mL MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 5 [hp_X] in 1 mL ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA 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 HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 10 [hp_X] in 1 mL ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA 3 [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 LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG 6 [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 WATER (UNII: 059QF0KO0R) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) PEPPERMINT OIL (UNII: AV092KU4JH) ALLANTOIN (UNII: 344S277G0Z) XYLITOL (UNII: VCQ006KQ1E) SODIUM BENZOATE (UNII: OJ245FE5EU) Product Characteristics Color yellow Score Shape Size Flavor PEPPERMINT Imprint Code Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/08/2021 Part 3 of 3 STELLALIFE VEGA ORAL CARE RINSE
rinse rinseProduct Information Item Code (Source) NDC:69685-103 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA 1 [hp_X] in 1 mL AZADIRACHTA INDICA BARK (UNII: G580B439YI) (AZADIRACHTA INDICA BARK - UNII:G580B439YI) AZADIRACHTA INDICA BARK 1 [hp_X] in 1 mL CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER 1 [hp_X] in 1 mL PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR 1 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength PROPOLIS WAX (UNII: 6Y8XYV2NOF) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) PEPPERMINT OIL (UNII: AV092KU4JH) POLYSORBATE 20 (UNII: 7T1F30V5YH) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) XYLITOL (UNII: VCQ006KQ1E) ALLANTOIN (UNII: 344S277G0Z) WATER (UNII: 059QF0KO0R) MENTHA PIPERITA LEAF (UNII: A389O33LX6) Product Characteristics Color yellow Score Shape Size Flavor PEPPERMINT Imprint Code Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/08/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/08/2021 STELLALIFE VEGA ORAL CARE
spray sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69685-111 Route of Administration SUBLINGUAL, DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 10 [hp_X] in 1 mL STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 30 [hp_X] in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 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 ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA 3 [hp_X] in 1 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 8 [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 ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 18 [hp_X] in 1 mL MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 5 [hp_X] in 1 mL ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA 3 [hp_X] in 1 mL LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG 6 [hp_X] in 1 mL DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED 8 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69685-111-01 1 in 1 BOX 01/08/2021 1 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/08/2021 Labeler - StellaLife, Inc. (079714251)
