STELLALIFE VEGA ORAL CARE COCONUT- risne rinse

StellaLife VEGA Oral Care Coconut by

Drug Labeling and Warnings

StellaLife VEGA Oral Care Coconut by is a Homeopathic medication manufactured, distributed, or labeled by StellaLife, Inc., Homeocare Laboratories, Inc., Homeocare Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Contains 0.25% of each of the following HPUS ingredients:

• Active Ingredients: Purpose
• Azadirachta indica 1X: Antigingivitis, swelling
• Apis mellifica 12X: Soothing, healing
• Calendula 1X: Antiseptic
• Echinacea purpurea 1X: Antiseptic
• Okoubaka aubrevellei 6X: Soothing, healing
• Phosphorous 12X: Anaglesic
• Plantago major 1X: Antiseptic
• Strontium 30X: Analgesic
• Thuja occidentalis 3X: Analgesic, soothing

Uses

Promotes oral health

Hydrates oral cavity

Supports healthy gums

Freshens breath

Usage

• Antimicrobial
• Promotes oral health
• Hydrates oral cavity
• Supports healthy gums
• Freshens breath.

Warnings

• 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

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

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

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

STELLALIFE VEGA ORAL CARE COCONUT 
risne rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69685-113
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD)	CALENDULA OFFICINALIS FLOWER	1 [hp_X]  in 1 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	12 [hp_X]  in 1 mL
AZADIRACHTA INDICA BARK (UNII: G580B439YI) (AZADIRACHTA INDICA BARK - UNII:G580B439YI)	AZADIRACHTA INDICA BARK	1 [hp_X]  in 1 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	3 [hp_X]  in 1 mL
ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98)	ECHINACEA PURPUREA	1 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X]  in 1 mL
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U)	PLANTAGO MAJOR	1 [hp_X]  in 1 mL
STRONTIUM (UNII: YZS2RPE8LE) (STRONTIUM - UNII:YZS2RPE8LE)	STRONTIUM	30 [hp_X]  in 1 mL
OKOUBAKA AUBREVILLEI BARK (UNII: MK2074187Z) (OKOUBAKA AUBREVILLEI BARK - UNII:MK2074187Z)	OKOUBAKA AUBREVILLEI BARK	6 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
COCONUT (UNII: 3RT3536DHY)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALLANTOIN (UNII: 344S277G0Z)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor	COCONUT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69685-113-16	1 in 1 BOX	01/08/2021
1		473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/08/2021

Labeler - StellaLife, Inc. (079714251)

Registrant - Homeocare Laboratories, Inc. (088248828)

Establishment
Name	Address	ID/FEI	Business Operations
Homeocare Laboratories Inc		088248828	manufacture(69685-113)