FDA.reportPublic FDA data

StellaLife VEGA Oral Care Oral Hydration Mist

Manufacturer
StellaLife, Inc.
Effective date
2025-12-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:34:13

Label at a glance#

ProductStellaLife VEGA Oral Care Oral Hydration Mist
Active ingredientCALENDULA OFFICINALIS FLOWER, PLANTAGO MAJOR, AZADIRACHTA INDICA BARK, ECHINACEA PURPUREA
Label structure10 sections

Indications and uses

Hydrates oral cavity Freshens breath Antimicrobial Promotes oral health

Dosage and administration

Adults and children over 6 years of age: Shake well. Spray 4 times per application. Repeat as needed or as directed by your doctor. 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.

Storage and handling

For your protection, this bottle has a full body seal. Do not use if 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.

Label contents#

Full prescribing information#

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children over 6 years of age: Shake well. Spray 4 times per application. Repeat as needed or as directed by your doctor. 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.

Warnings

WARNINGS SECTION

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

Active ingredients Purpose

OTC - ACTIVE INGREDIENT SECTION

Contains 0.55% of each of the following HPUS ingredients:

Azadirachta indica 1X.........Antigingivitis,

............................................swelling

Calendula 1X......................Antiseptic

Echinacea purpurea 1X......Antiseptic

Plantago major 1X..............Antiseptic

Questions?

OTC - QUESTIONS SECTION

1-800-828-7265 or info@stellalifehealing.com

Other information

STORAGE AND HANDLING SECTION

For your protection, this bottle has a full body seal. Do not use if 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.

Uses (continued)

INDICATIONS & USAGE SECTION

  • Hydrates oral cavity
  • Freshens breath
  • Antimicrobial
  • Promotes oral health

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • 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.

Drug Facts(continued) Uses

OTC - PURPOSE SECTION

  • Hydrates oral cavity
  • Freshens breath
  • Antimicrobial
  • Promotes oral health

StellaLife VEGA Oral Care Oral Hydration Mist

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

StellaLife Oral Hydration Mist Box LabelStellaLife Oral Hydration Mist Box Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69685-104-012025-12-24C16284748780-19d75b9d0-9574-f424-e053-dadaa90a57ceOral Hydration Mist
69685-104-012020-01-31C16284748780-19d75b9d0-9574-f424-e053-dadaa90a57ceOral Hydration Mist

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69685-10469685-104-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZIACT
WATER059QF0KO0RIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PEPPERMINT OILAV092KU4JHIACT
XYLITOLVCQ006KQ1EIACT
GLYCERINPDC6A3C0OXIACT
PROPOLIS CERA6Y8XYV2NOFIACT
PEPPERMINTV95R5KMY2BIACT
POLYSORBATE 207T1F30V5YHIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDACTIB
PLANTAGO MAJORW2469WNO6UACTIB
AZADIRACHTA INDICA BARKG580B439YIACTIB
ECHINACEA PURPUREAQI7G114Y98ACTIB

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
46e1b15d-cf7c-6b90-e063-6394a90a3b5762978d57-4cab-8280-e053-2a91aa0ac9db2025-12-26WarningsExact identifier
spl set id: 62978d57-4cab-8280-e053-2a91aa0ac9db

Reported adverse events (FAERS/openFDA)#

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