Active Ingredients
Azadirachta indica 3X
Calendula 3XX
Echinacea purpurea 3X
Plantago major 3X
Stellalife Vega Oral Care Vanilla Mint Rinse
FDA Label NDC 69685-173
13 label sections · Submitted to the FDA by Stellalife, Inc. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Stellalife, Inc. for the product Stellalife Vega Oral Care Vanilla Mint (NDC 69685-173). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, directions, keep out of reach of children, pregnancy and breast feeding, other information, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
| Active ingredient | Purpose |
| Azadirachta indica | Antigingivitis |
| Calendula | Antiseptic |
| Echinacea purpurea | Antiseptic |
| Plantago major | Antiseptic |
Uses
■ Promotes oral health.
■ Hydrates oral cavity.
■ Supports healthy gums.
■ Freshens breath.
Directions
For use over 12 years of age: Shake well.
Use 3/4 tablespoon (10 ml) per application
3 times a day. Swish in the mouth for
1 minute and then spit out. Do not
swallow. Refrain from eating or drinking
for at least 20 minutes after use.
Consult your healthcare professional
for use under 12 years of age.
Keep Out Of Reach Of Children
■ Keep this and all drugs out of the reach of children and pets. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.
Pregnancy And Breast Feeding
■ If pregnant or breast-feeding, ask a health professional before use.
Other Information
■ 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.
Warnings
Do not use if tamper evident cap seal is broken or missing.
■ Do not use if you have a known allergy or sensitivity to any of the ingredients.
Stop Use
■ Stop use and consult a healthcare professional if you experience irritation or unusual sensitivity, or develop a rash.
Otc - Ask Doctor
■ If pain, swelling or other related symptoms persist for more than 7 days of use, contact a dental professional.
Inactive Ingredients
Alcohol, Allantoin, Citric acid, Glycerin, Peppermint flavor, Potassium sorbate, Propolis, Purified water, Sodium benzoate, Xylitol.
Questions?
(305) 788-8555 or
[email protected]
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