GLAUCO- aconitum napellus, aurum metallicum, belladonna, causticum, cinchona officinalis, colchicum autumnale, euphrasia officinalis, gelsemium sempervirens, nux vomica, osmium metallicum, phosphorus, physostigma venenosum, rhus toxicodendron, spigelia anthelmia. 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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Glauco 4810L

INDICATIONS & USAGE SECTION

Formulated for symptoms such as blurred vision and red eyes..

DOSAGE & ADMINISTRATION SECTION

Directions: Adults take 6 drops by mouth one to four times daily or as directed by a health professional. Use in conjunction with eye exam.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Aconitum napellus 15x, Aurum metallicum 15x, Belladonna 15x, Causticum 15x, Cinchona officinalis 15x, Colchicum autumnale 15x, Euphrasia officinalis 15x, Gelsemium sempervirens 15x, Nux vomica 15x, Osmium metallicum 15x, Phosphorus 15x, Physostigma venenosum 15x, Rhus toxicodendron 15x, Spigelia anthelmia 15x.

OTC - PURPOSE SECTION

Formulated for symptoms such as blurred vision and red eyes.

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 Conyers, GA 30013

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

package label

GLAUCO
aconitum napellus, aurum metallicum, belladonna, causticum, cinchona officinalis, colchicum autumnale, euphrasia officinalis, gelsemium sempervirens, nux vomica, osmium metallicum, phosphorus, physostigma venenosum, rhus toxicodendron, spigelia anthelmia. liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-4810
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	15 [hp_X] in 1 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	15 [hp_X] in 1 mL
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU)	CAUSTICUM	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
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL)	EUPHRASIA STRICTA	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
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	15 [hp_X] in 1 mL
OSMIUM (UNII: 2E7M255OPY) (OSMIUM - UNII:2E7M255OPY)	OSMIUM	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
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	15 [hp_X] in 1 mL
SPIGELIA ANTHELMIA (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE)	SPIGELIA ANTHELMIA	15 [hp_X] in 1 mL
GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO)	GOLD	15 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55714-4810-1	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/02/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		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(55714-4810)