EYE FLOATERS- aloe, carbo veg., causticum,chelidonium majus, cholesterinum, cinchona, colchicum, cyclamen, gelsemium, kali carb., merc. viv.,phosphorus, hysostigma, prunus spin., senega officinalis, sepia, sulphur, tabacum, euphrasia liquid
Newton Laboratories, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Eye 4596L-Dis

INDICATIONS & USAGE SECTION

Eye Floaters Formulated for associated symptoms such as dark or grey specks and strings or cobwebs of material floating within the field of vision.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops orally one to four times daily or as directed by a healthcare professional. Warning: If an increase in floaters is accompanied by flashes of light or loss of peripheral vision, see an eye specialist immediately.

ACTIVE INGREDIENT SECTION

Aloe 15x, Carbo veg. 15x, Causticum 15x, Chelidonium majus 15x, Cholesterinum 15x, Cinchona 15x, Colchicum 15x, Cyclamen 15x, Gelsemium 15x, Kali carb. 15x, Merc. viv. 15x, Phosphorus 15x, Physostigma 15x, Prunus spin. 15x, Senega officinalis 15x, Sepia 15x, Sulphur 15x, Tabacum 15x, Euphrasia 3x.

PURPOSE SECTION

Formulated for associated symptoms such as dark or grey specks and strings or cobwebs of material floating within the field of vision.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.

QUESTIONS? SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.

PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.

KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

EYE FLOATERS
aloe, carbo veg., causticum,chelidonium majus, cholesterinum, cinchona, colchicum, cyclamen, gelsemium, kali carb., merc. viv.,phosphorus, hysostigma, prunus spin., senega officinalis, sepia, sulphur, tabacum, euphrasia liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:55714-4596
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9)	ALOE	15 [hp_X] in 1 mL
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10)	ACTIVATED CHARCOAL	15 [hp_X] in 1 mL
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU)	CAUSTICUM	15 [hp_X] in 1 mL
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS	15 [hp_X] in 1 mL
CHOLESTEROL (UNII: 97C5T2UQ7J) (CHOLESTEROL - UNII:97C5T2UQ7J)	CHOLESTEROL	15 [hp_X] in 1 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	15 [hp_X] in 1 mL
COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6)	COLCHICUM AUTUMNALE BULB	15 [hp_X] in 1 mL
CYCLAMEN PURPURASCENS TUBER (UNII: G728143D8Q) (CYCLAMEN PURPURASCENS TUBER - UNII:G728143D8Q)	CYCLAMEN PURPURASCENS TUBER	15 [hp_X] in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	15 [hp_X] in 1 mL
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D)	POTASSIUM CARBONATE	15 [hp_X] in 1 mL
MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL)	MERCURY	15 [hp_X] in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	15 [hp_X] in 1 mL
PHYSOSTIGMA VENENOSUM SEED (UNII: CJV9E9IIOA) (PHYSOSTIGMA VENENOSUM SEED - UNII:CJV9E9IIOA)	PHYSOSTIGMA VENENOSUM SEED	15 [hp_X] in 1 mL
PRUNUS SPINOSA FLOWER BUD (UNII: 53Y84VPS2W) (PRUNUS SPINOSA FLOWER BUD - UNII:53Y84VPS2W)	PRUNUS SPINOSA FLOWER BUD	15 [hp_X] in 1 mL
POLYGALA SENEGA ROOT (UNII: M7T6H7D4IF) (POLYGALA SENEGA ROOT - UNII:M7T6H7D4IF)	POLYGALA SENEGA ROOT	15 [hp_X] in 1 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	15 [hp_X] in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	15 [hp_X] in 1 mL
TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU)	TOBACCO LEAF	15 [hp_X] in 1 mL
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL)	EUPHRASIA STRICTA	3 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55714-4596-1	29.57 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	06/01/2011	09/02/2019
2	NDC:55714-4596-2	59.14 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	06/01/2011	09/02/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		06/01/2011	09/02/2019

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Name	Address	ID/FEI	Business Operations
Establishment
Newton Laboratories, Inc.		788793610	manufacture(55714-4596)

Revised: 12/2019

Document Id: 98bdd491-f722-14ca-e053-2a95a90aef24

Set id: e5402190-6342-9d6d-17d9-75dd2dcb20a5

Version: 4

Effective Time: 20191202

Newton Laboratories, Inc.