Label: STELLALIFE VEGA ORAL CARE GEL- gel gel
STELLALIFE VEGA ORAL CARE RECOVERY KIT- kit kit
STELLALIFE VEGA ORAL CARE- spray spray
- NDC Code(s): 61727-115-01, 61727-117-01, 61727-118-01
- Packager: Homeocare Laboratories, 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 8, 2021
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StellaLife VEGA Oral Care Spray
Drug Facts
Contains 7.14% 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, wound healing Ignata 30X Soothing Ledum Palusttre 6X Analgesic, antiseptic Ruta 12X Bruising Silicea 8X Analgesic, antiseptic Staphysagria 8X Analgesic, soothing 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 odf 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 dday or as directed by your doctor. Consult a healthcare professional for use in children under 6 years of age.
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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 Uses
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 odf 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
Drug Facts
Contains 0.55% of each of the following HPUS ingredients:
Active Ingredient Purpose Azadirachta Indica 1X Antiginivitis, swelling Calendula 1X Antiseptic Echinacea Purpurea 1X Antiseptic Plantago Major 1X Antiseptic 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 odf 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.
- Rinse Principal Display Panel
- Recovery Kit Principal Display Panel
- Spray Principal Display Panel
- Gel Principal Display Panel
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INGREDIENTS AND APPEARANCE
STELLALIFE VEGA ORAL CARE GEL
gel gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61727-117 Route of Administration TOPICAL, DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 8 [hp_X] in 1 mL STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 30 [hp_X] in 1 mL DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED 8 [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 RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP 12 [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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 8 [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 CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 3 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM BENZOATE (UNII: OJ245FE5EU) WATER (UNII: 059QF0KO0R) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) ALLANTOIN (UNII: 344S277G0Z) XYLITOL (UNII: VCQ006KQ1E) PEPPERMINT OIL (UNII: AV092KU4JH) Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61727-117-01 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
kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61727-115 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61727-115-01 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:61727-118 Route of Administration SUBLINGUAL, DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 3 [hp_X] in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 8 [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 MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 5 [hp_X] in 1 mL STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 30 [hp_X] in 1 mL ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 18 [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 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 PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA 3 [hp_X] in 1 mL ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA 3 [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 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:61727-117 Route of Administration TOPICAL, DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 30 [hp_X] in 1 mL DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED 8 [hp_X] in 1 mL ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA 3 [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 CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 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 ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 18 [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 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 MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 5 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) ALLANTOIN (UNII: 344S277G0Z) PEPPERMINT OIL (UNII: AV092KU4JH) XYLITOL (UNII: VCQ006KQ1E) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) 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 3 of 3 STELLALIFE VEGA ORAL CARE RINSE
rinse rinseProduct Information Item Code (Source) NDC:61727-103 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 POLYSORBATE 20 (UNII: 7T1F30V5YH) PEPPERMINT OIL (UNII: AV092KU4JH) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PROPOLIS WAX (UNII: 6Y8XYV2NOF) ALLANTOIN (UNII: 344S277G0Z) MENTHA PIPERITA LEAF (UNII: A389O33LX6) XYLITOL (UNII: VCQ006KQ1E) GLYCERIN (UNII: PDC6A3C0OX) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) 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:61727-118 Route of Administration SUBLINGUAL, DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 3 [hp_X] in 1 mL ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA 3 [hp_X] in 1 mL STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 30 [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 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 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 LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG 6 [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 CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61727-118-01 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 - Homeocare Laboratories, Inc. (088248828) Registrant - Homeocare Laboratories, Inc. (088248828) Establishment Name Address ID/FEI Business Operations Homeocare Laboratories Inc 088248828 manufacture(61727-117, 61727-115, 61727-118)