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NDC 69685-0113-16 StellaLife VEGA Oral Care Coconut 12; 1; 1; 1; 6; 12; 1; 30; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Details

StellaLife VEGA Oral Care Coconut 12; 1; 1; 1; 6; 12; 1; 30; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL

StellaLife VEGA Oral Care Coconut is a DENTAL RINSE in the HUMAN OTC DRUG category. It is labeled and distributed by StellaLife, Inc.. The primary component is APIS MELLIFERA; AZADIRACHTA INDICA BARK; CALENDULA OFFICINALIS FLOWER; ECHINACEA PURPUREA; OKOUBAKA AUBREVILLEI BARK; PHOSPHORUS; PLANTAGO MAJOR; STRONTIUM; THUJA OCCIDENTALIS LEAFY TWIG.

Product Information

NDC	69685-0113
Product ID	69685-113_ca787fd0-fddb-8961-e053-2a95a90a9d88
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	StellaLife VEGA Oral Care Coconut
Proprietary Name Suffix	n/a
Non-Proprietary Name	Risne
Product Type	HUMAN OTC DRUG
Dosage Form	RINSE
Route	DENTAL
Active Ingredient Strength	12; 1; 1; 1; 6; 12; 1; 30; 3
Active Ingredient Units	[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Substance Name	APIS MELLIFERA; AZADIRACHTA INDICA BARK; CALENDULA OFFICINALIS FLOWER; ECHINACEA PURPUREA; OKOUBAKA AUBREVILLEI BARK; PHOSPHORUS; PLANTAGO MAJOR; STRONTIUM; THUJA OCCIDENTALIS LEAFY TWIG
Labeler Name	StellaLife, Inc.
Pharmaceutical Class	Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69685-0113-16 (69685011316)

Pricing Information	N/A
NDC Package Code	69685-113-16
Billing NDC	69685011316
Package	1 BOTTLE, PLASTIC in 1 BOX (69685-113-16) / 473 mL in 1 BOTTLE, PLASTIC
Marketing Start Date	2021-01-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b8694e38-dc05-77c9-e053-2995a90a36e4 Details

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/08/2021

Labeler - StellaLife, Inc. (079714251)

Registrant - Homeocare Laboratories, Inc. (088248828)

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

Revised: 8/2021

Document Id: ca787fd0-fddb-8961-e053-2a95a90a9d88

Set id: b8694e38-dc05-77c9-e053-2995a90a36e4

Version: 4

Effective Time: 20210826