Active Ingredients
Azadirachta indica 3X
Calendula 3X
Echinacea purpurea 3X
Plantago major 3X
Stellalife Vega Oral Care Cucumber Rinse
FDA Label NDC 69685-123
Full FDA labeling including 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 Cucumber (NDC 69685-123). 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, swelling |
| Calendula | Antiseptic |
| Echinacea purpurea | Antiseptic |
| Plantago major | Antiseptic |
Uses
■ Antimicrobial.
■ Promotes oral health.
■ Hydrates oral cavity.
■ Supports healthy gums.
■ Freshens breath.
Directions
Adults and children over the age of 6 years: Shake well. Use 3/4 tablespoon (10 ml) per application 3 times a day or as recommended by a dental professional. Swish in the mouth for 1-2 minutes 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 in children under 6 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
■ As with any drug, if you are pregnant or nursing a baby, seek the advice of a healthcare professional before using this product.
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
For your protection, this bottle has an inner seal under the cap. Do not use if tamper evident cap seal is broken or missing.
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, Cucumber flavor, Glycerin, Potassium sorbate, Propolis, Purified water, Sodium benzoate, Xylitol.
Questions?
(305) 788-8555 or
[email protected]
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