FDA.reportPublic FDA data

StellaLife VEGA Oral Care

Manufacturer
Homeocare Laboratories, Inc. | Homeocare Laboratories Inc
Effective date
2025-12-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:36:27

Label at a glance#

ProductStellaLife VEGA Oral Care Gel
Active ingredientCALCIUM SULFIDE, STRYCHNOS IGNATII SEED, DELPHINIUM STAPHISAGRIA SEED, ARNICA MONTANA, MATRICARIA RECUTITA, RUTA GRAVEOLENS FLOWERING TOP, HYPERICUM PERFORATUM, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, ECHINACEA PURPUREA, LEDUM PALUSTRE TWIG, CALENDULA OFFICINALIS FLOWERING TOP, AZADIRACHTA INDICA BARK, CALENDULA OFFICINALIS FLOWER, PLANTAGO MAJOR
Label structure7 sections

Label contents#

Full prescribing information#

StellaLife VEGA Oral Care Spray

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Contains 7.14% each of the following HPUS Ingredients

Active IngredientsPurpose
Arnica 3X, 6X, 18XBruising, swelling
Calendula 3XAntiseptic
Chamomilla 5XSwelling
Echinacea Angustifolia 3XAntiseptic
Echinacea Purpurea 3XAntiseptic
Hepar Sulph Calc 8XAntiseptic
Hypericum 10XBruising, wound healing
Ignata 30XSoothing
Ledum Palusttre 6XAnalgesic, antiseptic
Ruta 12XBruising
Silicea 8XAnalgesic, antiseptic
Staphysagria 8XAnalgesic, soothing

Usage

INDICATIONS & USAGE SECTION

Pain and swelling relief

Promotes Healing

Reduces Bruising

Uses

OTC - PURPOSE SECTION

Temporarily

  • Relieves pain and swelling.
  • Promotes healing.
  • Reduces bruising.

Warnings

WARNINGS SECTION

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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.

Other information

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

Citric acid, Glycerin, Potassium sorbate, Purified water.

StellaLife VEGA Oral Care Gel

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Contains 0.0714% of each of the following HPUS ingredients:

Active IngredientsPurpose
Arnica 3X, 6X, 18XBruising, swelling
Calendula 3XAntiseptic
Chamomilla 5XSwelling
Echinacea angustifolia 3XAntiseptic
Echinacea purpurea 3XAntiseptic
Hepar sulph calc 8XAntiseptic
Hypericum 10XBruising, would healing
Ignata 30XSoothing
Ledum palustre 6XAnalgesic
Ruta 12XBruising
Silicea 8XAnalgesic, antiseptic
Staphysagria 8XAnalgesic, soothing

Usage

INDICATIONS & USAGE SECTION

Promotes healing

Reduces bruising

Relieves oral ulcers

Hydrates oral cavity

Uses

OTC - PURPOSE SECTION

Temporarily

  • Relieves pain and swelling.
  • Promotes healing.
  • Reduces bruising.
  • Relieves oral ulcers.
  • Hydrates oral cavity.

Warnings

WARNINGS SECTION

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Adults and children over the age of 6 years: Wash hands.Apply to the gum at the surgical or affected areawith 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.

Other information

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

Allantoin, Hydroxyethylcellulose, Peppermint oil, Purified water, Sodium benzoate, Xylitol

StellaLife VEGA Oral Care Rinse

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Contains 0.55% of each of the following HPUS ingredients:

Active IngredientPurpose
Azadirachta Indica 1XAntiginivitis, swelling
Calendula 1XAntiseptic
Echinacea Purpurea 1XAntiseptic
Plantago Major 1XAntiseptic

Uses

INDICATIONS & USAGE SECTION

Promotes oral health

Hydrates oral cavity

Supports healthy gums

Freshens breath

Usage

OTC - PURPOSE SECTION

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

Warnings

WARNINGS SECTION

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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

Rinse Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rinse DisplayRinse Display

Recovery Kit Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kit LabelKit Label

Spray Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Spray LabelSpray Label

Gel Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gel LabelGel Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codestellalife.com/Stellalife Recovery Kit Display.jpg, Stellalife Gel Display.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61727-115-01StellaLife VEGA Oral Care Recovery Kit1 in 1 BOXKIT13
61727-117-01StellaLife VEGA Oral Care Gel30 mL in 1 BOTTLE, PUMPGEL303
61727-117-01StellaLife VEGA Oral Care Gel1 in 1 BOXGEL13
61727-118-01StellaLife VEGA Oral Care30 mL in 1 BOTTLE, SPRAYSPRAY303
61727-118-01StellaLife VEGA Oral Care1 in 1 BOXSPRAY13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61727-11761727-117-01
61727-11561727-115-01
61727-11861727-118-01
61727-103

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 3 · 82 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPIACT
ALLANTOIN344S277G0ZIACT
XYLITOLVCQ006KQ1EIACT
PEPPERMINT OILAV092KU4JHIACT
CALCIUM SULFIDE1MBW07J51QACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
DELPHINIUM STAPHISAGRIA SEED00543AP1JVACTIB
ARNICA MONTANAO80TY208ZWACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
RUTA GRAVEOLENS FLOWERING TOPN94C2U587SACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
ECHINACEA PURPUREAQI7G114Y98ACTIB
LEDUM PALUSTRE TWIG877L01IZ0PACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
LEDUM PALUSTRE TWIG877L01IZ0PACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
ARNICA MONTANAO80TY208ZWACTIB
RUTA GRAVEOLENS FLOWERING TOPN94C2U587SACTIB
DELPHINIUM STAPHISAGRIA SEED00543AP1JVACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
ECHINACEA PURPUREAQI7G114Y98ACTIB
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
ALLANTOIN344S277G0ZIACT
PEPPERMINT OILAV092KU4JHIACT
XYLITOLVCQ006KQ1EIACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
StellaLife VEGA Oral Care Recovery KitKITHomeocare Laboratories, Inc.b701234a-0bd2-16d3-e053-2995a90a5b132025-12-24WarningsExact identifier
ndc (package): 61727-115-01
ndc (package): 61727-118-01
ndc (package): 61727-117-01
ndc (product): 61727-118
ndc (product): 61727-115
ndc (product): 61727-117
ndc11 (package): 61727011501
ndc11 (package): 61727011701
ndc11 (package): 61727011801
spl id: 46bb1906-1c41-bfa8-e063-6294a90aed63
spl set id: b701234a-0bd2-16d3-e053-2995a90a5b13
StellaLife VEGA Oral CareSPRAYHomeocare Laboratories, Inc.46f3ff78-f5fc-6da1-e054-00144ff8d46c2025-12-24WarningsExact identifier
ndc (product): 61727-103

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.