Stellalife Vega Oral Care Spearmint Rinse
StellaLife VEGA Oral Care Spearmint Rinse
Vega Oral Care Recovery Kit
FDA Label NDC 69685-107
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 Vega Oral Care Recovery (NDC 69685-107). 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 stellalife vega oral care spearmint rinse, cucumber rinse active ingredient, purpose, uses, directions, keep out of reach of children, pregnancy and breast feeding, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Cucumber Rinse Active Ingredient
Azadirachta indica 3X
Calendula 3X
Echinacea purpurea 3X
Plantago major 3X
Purpose
| Active ingredient | Purpose |
| Azadirachta indica | Antigingivitis, swelling |
| Calendula | Antiseptic |
| Echinacea purpurea | Antiseptic |
| Plantago major | Antiseptic |
| Active Ingredient | Purpose |
| Arnica | Bruising, swelling |
| Calendula | Antiseptic |
| Chamomilla | Swelling |
| Echinacea angustifolia | Antiseptic |
| Echinacea purpurea | Antiseptic |
| Hepar sulph calc | Antiseptic |
| Hypericum | Bruising, wound healing |
| lgnatia | Soothing |
| Ledum palustre | Analgesic |
| Ruta | Bruising |
| Silicea | Analgesic, antiseptic |
| Staphysagria | Analgesic, soothing |
| Active Ingredient | Purpose |
| Arnica | Bruising, swelling |
| Calendula | Antiseptic |
| Chamomilla | Swelling |
| Echinacea angustifolia | Antiseptic |
| Echinacea purpurea | Antiseptic |
| Hepar sulph calc | Antiseptic |
| Hypericum | Bruising, wound healing |
| lgnatia | Soothing |
| Ledum palustre | Analgesic |
| Ruta | Bruising |
| Silicea | Analgesic, antiseptic |
| Staphysagria | Analgesic, soothing |
Uses
■ Antimicrobial.
■ Promotes oral health.
■ Hydrates oral cavity.
■ Supports healthy gums.
■ Freshens breath.
Temporarily
- Relieves pain and swelling.
- Promotes healing.
- Reduces bruising.
- Relieves oral ulcers.
- Hydrates oral
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.
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.
Adults and children over the age of 6 years: Wash hands. Apply to the gum at the surgical or affected area with a cotton swab. Allow gel to dissolve. Do not eat or drink for 20 minutes after application. Apply 4 times per day or as directed by a dental professional. Consult your healthcare professional for use in children under6 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.
■ 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.
■ 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.
■ 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
■ 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
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.
For your protection, this bottle has a full body seal. Do not use if this tamper evident seal is broken or missing.
For your protection this container has a seal. Do not use if this tamper evident 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.
■ Stop use and consult a healthcare professional if you experience irritation or unusual sensitivity, or develop a rash.
■ Stop use and consult a health professional is you experience irritation or unusual sensitivity, or develop a rash,
Ask Doctor
■ If pain, swelling or other related symptoms persist for more than 7 days of use, contact a dental professional.
Inactive Ingredient
Alcohol, Allantoin, Citric acid, Cucumber flavor, Glycerin, Potassium sorbate, Propolis, Purified water, Sodium benzoate, Xylitol.
Questions?
Unflavored Spray
Unflavored Spray
Unflavored Spray Active Ingredients
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
Unflavored Spray Pregnancy
■ As with any drug, if you are pregnant or nursing a baby, seek the advice of a healthcare professional before using this product.
Unflavored Spray Uses
■ Relieves pain and swelling.
■ Promotes healing.
■ Reducing bruising.
Do Not Use
■ Do not use if you have a known allergy or sensitivity to any of the ingredients.
■ Do not use if you have a known allergy or sensitivity to any of the ingredients.
Ask Dental Professional
■ If pain, swelling or other related symptoms persist for more than 7 days of use, contact a dental professional.
■ If pain, swelling or other related symptoms persist for more than7 days of use, contact a dental professional.
Unflavored Gel
Unflavored Gel
Pregnancy
■ As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.
Inactive Ingredients
Allantoin, Hydroxyethylcellulose, Potassium sorbate, Purified water, Sodium benzoate, Sodium metabisulfite, Xylitol.
Unflavored Gel Active Ingredients
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
Package Label.Principal Display Panel
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