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Occuloplex G Prescribing Information

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

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.

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.

DIRECTIONS:

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

INDICATIONS:

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
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 Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:43857-0461
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EUPHRASIA STRICTA (EUPHRASIA STRICTA) EUPHRASIA STRICTA 3 [hp_X] in 1 mL
GINKGO (GINKGO) GINKGO 3 [hp_X] in 1 mL
PETROSELINUM CRISPUM (PETROSELINUM CRISPUM) PETROSELINUM CRISPUM 3 [hp_X] in 1 mL
BILBERRY (BILBERRY) BILBERRY 3 [hp_X] in 1 mL
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 6 [hp_X] in 1 mL
SPIGELIA ANTHELMIA (SPIGELIA ANTHELMIA) SPIGELIA ANTHELMIA 6 [hp_X] in 1 mL
SUS SCROFA EYE (SUS SCROFA EYE) SUS SCROFA EYE 6 [hp_X] in 1 mL
GERMANIUM SESQUIOXIDE (GERMANIUM SESQUIOXIDE) GERMANIUM SESQUIOXIDE 8 [hp_X] in 1 mL
LITHIUM (LITHIUM CATION) LITHIUM 8 [hp_X] in 1 mL
UBIDECARENONE (UBIDECARENONE) UBIDECARENONE 8 [hp_X] in 1 mL
GOLD (GOLD) GOLD 12 [hp_X] in 1 mL
BRYONIA ALBA ROOT (BRYONIA ALBA ROOT) BRYONIA ALBA ROOT 12 [hp_X] in 1 mL
CALCIUM SULFIDE (CALCIUM SULFIDE) CALCIUM SULFIDE 12 [hp_X] in 1 mL
PHOSPHORUS (PHOSPHORUS) PHOSPHORUS 12 [hp_X] in 1 mL
RUTA GRAVEOLENS FLOWERING TOP (RUTA GRAVEOLENS FLOWERING TOP) RUTA GRAVEOLENS FLOWERING TOP 12 [hp_X] in 1 mL
SULFUR (SULFUR) SULFUR 12 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
Packaging
# Item Code Package Description
1 NDC:43857-0461-1 30 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 09/06/2017 10/16/2022
Labeler - BioActive Nutritional, Inc. (624980496)
Registrant - Apotheca Company (844330915)
Establishment
Name Address ID/FEI Operations
Apotheca Company 844330915 manufacture(43857-0461), api manufacture(43857-0461), label(43857-0461), pack(43857-0461)
BioActive Nutritional, Inc.

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