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Occuloplex G: Package Insert / Prescribing Info

Package insert / product label
Generic name: homeopathic product
Dosage form: oral liquid

ACTIVE INGREDIENTS:

Euphrasia Officinalis 3X, Ginkgo Biloba 3X, Petroselinum Sativum 3X, Vaccinium Myrtillus 3X, Ascorbic Acid 6X, Spigelia Anthelmia 6X, Eye (Suis) 6X, 9X, Germanium Sesquioxide 8X, Lithium Metallicum 8X, Ubidecarenonum 8X, Aurum Metallicum 12X, Bryonia (Alba) 12X, Hepar Sulphuris Calcareum 12X, Phosphorus 12X, Ruta Graveolens 12X, Sulphur 12X.

INDICATIONS:

For temporary relief of pressure in the eyes, and pain in and around the eyes.

Warnings

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Occuloplex G Dosage and Administration

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Indications and Usage for Occuloplex G

For temporary relief of pressure in the eyes, and pain in and around the eyes.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol.

QUESTIONS:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

PACKAGE LABEL DISPLAY:

BIOActive Nutritional

OCCULOPLEX G

HOMEOPATHIC

1 FL OZ (30 ml)

Occuloplex G

OCCULOPLEX G
euphrasia officinalis, ginkgo biloba, petroselinum sativum, vaccinium myrtillus, ascorbic acid, spigelia anthelmia, eye (suis), germanium sesquioxide, lithium metallicum, ubidecarenonum, aurum metallicum, bryonia (alba), hepar sulphuris calcareum, phosphorus, ruta graveolens, sulphur liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43857-0461
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA3 [hp_X] in 1 mL
GINKGO (UNII: 19FUJ2C58T) (GINKGO - UNII:19FUJ2C58T) GINKGO3 [hp_X] in 1 mL
PETROSELINUM CRISPUM (UNII: 1WZA4Y92EX) (PETROSELINUM CRISPUM - UNII:1WZA4Y92EX) PETROSELINUM CRISPUM3 [hp_X] in 1 mL
BILBERRY (UNII: 9P2U39H18W) (BILBERRY - UNII:9P2U39H18W) BILBERRY3 [hp_X] in 1 mL
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID6 [hp_X] in 1 mL
SPIGELIA ANTHELMIA (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE) SPIGELIA ANTHELMIA6 [hp_X] in 1 mL
SUS SCROFA EYE (UNII: X3AOK514E6) (SUS SCROFA EYE - UNII:X3AOK514E6) SUS SCROFA EYE6 [hp_X] in 1 mL
GERMANIUM SESQUIOXIDE (UNII: 96WE91N25T) (GERMANIUM SESQUIOXIDE - UNII:96WE91N25T) GERMANIUM SESQUIOXIDE8 [hp_X] in 1 mL
LITHIUM (UNII: 9FN79X2M3F) (LITHIUM CATION - UNII:8H8Z5UER66) LITHIUM8 [hp_X] in 1 mL
UBIDECARENONE (UNII: EJ27X76M46) (UBIDECARENONE - UNII:EJ27X76M46) UBIDECARENONE8 [hp_X] in 1 mL
GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO) GOLD12 [hp_X] in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT12 [hp_X] in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X] in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X] in 1 mL
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP12 [hp_X] in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X] in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43857-0461-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product09/06/201710/16/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/06/201710/16/2022
Labeler - BioActive Nutritional, Inc. (624980496)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43857-0461) , api manufacture(43857-0461) , label(43857-0461) , pack(43857-0461)