FDA.reportPublic FDA data

StellaLife VEGA Oral Care Coconut

Manufacturer
StellaLife, Inc.
Effective date
2025-12-23
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:36:27

Label at a glance#

ProductStellaLife VEGA Oral Care Coconut
Active ingredientCALENDULA OFFICINALIS FLOWER, APIS MELLIFERA, AZADIRACHTA INDICA BARK, THUJA OCCIDENTALIS LEAFY TWIG, ECHINACEA PURPUREA, PHOSPHORUS, PLANTAGO MAJOR, STRONTIUM, OKOUBAKA AUBREVILLEI BARK
Label structure9 sections

Indications and uses

Promotes oral health Hydrates oral cavity Supports healthy gums Freshens breath

Dosage and administration

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.

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Contains 0.25% of each of the following HPUS ingredients:

Active IngredientsPurpose
Azadirachta indica 1XAntigingivitis, swelling
Apis mellifica 12XSoothing, healing
Calendula 1XAntiseptic
Echinacea purpurea 1XAntiseptic
Okoubaka aubrevellei 6XSoothing, healing
Phosphorous 12XAnaglesic
Plantago major 1XAntiseptic
Strontium 30XAnalgesic
Thuja occidentalis 3XAnalgesic, soothing

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 of 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, WATER, XYLITOL, POTASSIUM SORBATE, COCONUT, CITRIC ACID MONOHYDRATE, GLYCERIN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rinse BoxRinse Box

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850019861020GTIN-13: 0850019861020
EAN-13: 0850019861020
GTIN-12: 850019861020
UPC-A: 850019861020
GTIN storage (14 digits): 00850019861020		RINSE BOX_Coconut_16oz_12.18.20-min.jpg
QR code linkQR Codestellalife.com/RINSE BOX_Coconut_16oz_12.18.20-min.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69685-113-16StellaLife VEGA Oral Care Coconut1 in 1 BOXRINSE15
69685-113-16StellaLife VEGA Oral Care Coconut473 mL in 1 BOTTLE, PLASTICRINSE4735

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69685-11369685-113-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
XYLITOLVCQ006KQ1EIACT
PROPOLIS WAX6Y8XYV2NOFIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
COCONUT3RT3536DHYIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ALLANTOIN344S277G0ZIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDACTIB
APIS MELLIFERA7S82P3R43ZACTIB
AZADIRACHTA INDICA BARKG580B439YIACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
ECHINACEA PURPUREAQI7G114Y98ACTIB
PHOSPHORUS27YLU75U4WACTIB
PLANTAGO MAJORW2469WNO6UACTIB
STRONTIUMYZS2RPE8LEACTIB
OKOUBAKA AUBREVILLEI BARKMK2074187ZACTIB

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
StellaLife VEGA Oral Care CoconutRISNEStellaLife, Inc.b8694e38-dc05-77c9-e053-2995a90a36e42025-12-23WarningsExact identifier
ndc (package): 69685-113-16
ndc (product): 69685-113
ndc11 (package): 69685011316
spl id: 46ac489f-90ca-4680-e063-6394a90a0a20
spl set id: b8694e38-dc05-77c9-e053-2995a90a36e4

Reported adverse events (FAERS/openFDA)#

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