FDA.reportPublic FDA data

SPRAY - Unflavored - StellaLife

Manufacturer
StellaLife, Inc.
Effective date
2025-12-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:36:25

Label at a glance#

ProductStellaLife VEGA Oral Care Pain and Swelling Relief
Active ingredientHYPERICUM PERFORATUM, STRYCHNOS IGNATII SEED, SILICON DIOXIDE, CALENDULA OFFICINALIS FLOWERING TOP, ECHINACEA ANGUSTIFOLIA, CALCIUM SULFIDE, RUTA GRAVEOLENS FLOWERING TOP, ARNICA MONTANA, MATRICARIA RECUTITA, ECHINACEA PURPUREA, LEDUM PALUSTRE TWIG, DELPHINIUM STAPHISAGRIA SEED
Label structure14 sections

Indications and uses

■ Relieves pain and swelling. ■ Promotes healing. ■ Reducing bruising.

Dosage and administration

Adults and children over 6 years of age: Shake well . Spray 3-4 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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Arnica 3X, 6X, 18X, Calendula 3X, Chamomilla 5X, Echinacea angustifolia 3X, Echinacea purpurea 3X, Hepar sulph calc 8X, Hypericum 10X, lgnatia 30X, Ruta 12X, Silicea 8X, Staphysagria 8X

Purpose

OTC - PURPOSE SECTION

Active IngredientPurpose
ArnicaBruising, swelling
CalendulaAntiseptic
ChamomillaSwelling
Echinacea angustifoliaAntiseptic
Echinacea purpureaAntiseptic
Hepar sulph calcAntiseptic
HypericumBruising, wound healing
lgnatiaSoothing
Ledum palustreAnalgesic
RutaBruising
SiliceaAnalgesic, antiseptic
StaphysagriaAnalgesic, soothing

Keep out of reach of children

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.

Pregnancy

OTC - PREGNANCY OR BREAST FEEDING SECTION

■ As with any drug, if you are pregnant or nursing a baby, seek the advice of a healthcare professional before using this product.

Warnings

WARNINGS SECTION

For your protection, this bottle has a full body seal. Do not use if this tamper evident seal is broken or missing.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children over 6 years of age: Shake well. Spray 3-4 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.

Uses

INDICATIONS & USAGE SECTION

■ Relieves pain and swelling.

■ Promotes healing.

■ Reducing bruising.

Do not use

OTC - DO NOT USE SECTION

■ Do not use if you have a known allergy or sensitivity to any of the ingredients.

Stop use

OTC - STOP USE SECTION

■ Stop use and consult a healthcare professional if you experience irritation or unusual sensitivity, or develop a rash.

Ask dental professional

OTC - ASK DOCTOR SECTION

■ If pain, swelling or other related symptoms persist for more than 7 days of use, contact a dental professional.

Other information

SPL UNCLASSIFIED SECTION

■ Store at room temperature.

■ Keep away from direct heat or sunlight.

■ Because of natural ingredients. color may vary overtime.

■ Use within 60 days of opening

Questions?

OTC - QUESTIONS SECTION

(305) 788-8555 or

Support@StellaLife.com

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Citric acid, Glycerine, Potassium sorbate, Purified water, Sodium Benzoate

StellaLife VEGA Oral Care Spray Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 1Label 1

Label 2Label 2

Label 3Label 3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69685-121-01StellaLife VEGA Oral CarePain and Swelling Relief1 in 1 BOXSPRAY13
69685-121-01StellaLife VEGA Oral CarePain and Swelling Relief30 mL in 1 BOTTLE, SPRAYSPRAY303

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
69685-12169685-121-01

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
SODIUM BENZOATEOJ245FE5EUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
RUTA GRAVEOLENS FLOWERING TOPN94C2U587SACTIB
ARNICA MONTANAO80TY208ZWACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
ECHINACEA PURPUREAQI7G114Y98ACTIB
LEDUM PALUSTRE TWIG877L01IZ0PACTIB
DELPHINIUM STAPHISAGRIA SEED00543AP1JVACTIB

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 Pain and Swelling ReliefARNICA, CALENDULA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, HEPAR SULPH CALC, HYPERICUM, LGNATIA, RUTA, STAPHYSAGRIAStellaLife, Inc.10f8dee1-d5d3-0602-e063-6294a90a6dbf2025-12-22WarningsExact identifier
ndc (package): 69685-121-01
ndc (product): 69685-121
ndc11 (package): 69685012101
spl id: 468e5f46-faad-626e-e063-6294a90af09e
spl set id: 10f8dee1-d5d3-0602-e063-6294a90a6dbf

Reported adverse events (FAERS/openFDA)#

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