FDA.reportPublic FDA data

N10

Manufacturer
Apex Energetics Inc.
Effective date
2024-01-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:25:28

Key Label Information#

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Allium Cepa 1X Allium Sativum 1X Baryta Iodata 4X 6X 8X 10X Berberis Vulgaris 1X Carduus Marianus 1X Chenopodium Anthelminticum 1X Chininum Arsenicosum 6X 9X Cina 2X 4X 6X Cinchona Officinalis 6X 9X Croton Tiglium 3X Echinacea Angustifolia 1X Hydrastis Canadensis 1X Illicium Anisatum 2X Lycopodium Clavatum 6X 9X 12X Natrum Phosphoricum 6X 8X 12X Rhamnus Purshiana 1X Santoninum 6X 8X Scrophularia Nodosa 3X Senna 1X Sulphur 6C 9C Tanacetum Vulgare 4X 8X Teucrium Marum 2X 6X 8X

Warnings

Warnings:

Directions And Dosage

Directions:

Adults & children ages 12 years and over: Take 10 drops under the tongue 3 times a day, or as directed by your healthcare professional. Consult a physician for use in children under 12 years of age.

Other Label Information

Inactive Ingredients

alcohol (20% by volume), glycerin, distilled water

OTC - QUESTIONS SECTION

Distributed by Apex Energetics. Questions? 16592 Hale Ave., Irvine, CA 92606, USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FUTUREPLEX® N10 ANTITOX® PARAKLENZ™ Homeopathic Formula Digestive Discomfort* Diarrhea* Skin Rash* 1 fl oz (30 mL) Alcohol 20% by Volume

Label Images#

N10 PARAKLENZ 20210409
N10 PARAKLENZ 20210409

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
22bca8fc-c2b1-897d-b515-117a7522ccaeProduct name320150731
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63479-1410-1N10PARAKLENZ30 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63479-1410N10 PARAKLENZ (ALLIUM CEPA, ALLIUM SATIVUM, BARYTA IODATA, BERBERIS VULGARIS, CARDUUS MARIANUS, CHENOPODIUM ANTHELMINTICUM, CHININUM ARSENICOSUM, CINA, CINCHONA OFFICINALIS, CROTON TIGLIUM, ECHINACEA ANGUSTIFOLIA, HYDRASTIS CANADENSIS, ILLICIUM ANISATUM, LYCOPODIUM CLAVATUM, NATRUM PHOSPHORICUM, RHAMNUS PURSHIANA, SANTONINUM, SCROPHULARIA NODOSA, SENNA, SULPHUR, TANACETUM VULGARE, TEUCRIUM MARUM) SOLUTION/ DROPS [APEX ENERGETICS INC.]2Current NDC, Legacy NDC, 1 package rows20240110_beff36e8-e976-84fa-e053-2a95a90adcb9.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63479-141063479-1410-1

Ingredients#

Name, UNII, Kind table
NameUNIIKind
TEUCRIUM MARUM10464S0TAAACTIB
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ONION492225Q21HACTIB
GARLICV1V998DC17ACTIB
SCROPHULARIA NODOSA7H443NUB2TACTIB
TANACETUM VULGARE TOPD52957JQ8MACTIB
ALCOHOL3K9958V90MIACT
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
GOLDENSEALZW3Z11D0JVACTIB
STAR ANISEXKC1657P78ACTIB
FRANGULA PURSHIANA BARK4VBP01X99FACTIB
SANTONIN1VL8J38EROACTIB
ARTEMISIA CINA FLOWER28M1820ACTACTIB
MILK THISTLEU946SH95EEACTIB
CHENOPODIUM AMBROSIOIDES4H5RSU087IACTIB
QUININE ARSENITE42QO5P0NLMACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
CROTON TIGLIUM SEED0HK2GZK66EACTIB
SENNA LEAFAK7JF626KXACTIB
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE70WT22SF4BACTIB
SULFUR70FD1KFU70ACTIB
BARIUM IODIDEWKC4T7680AACTIB
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB

Complete SPL Sections#

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Allium Cepa 1X Allium Sativum 1X Baryta Iodata 4X 6X 8X 10X Berberis Vulgaris 1X Carduus Marianus 1X Chenopodium Anthelminticum 1X Chininum Arsenicosum 6X 9X Cina 2X 4X 6X Cinchona Officinalis 6X 9X Croton Tiglium 3X Echinacea Angustifolia 1X Hydrastis Canadensis 1X Illicium Anisatum 2X Lycopodium Clavatum 6X 9X 12X Natrum Phosphoricum 6X 8X 12X Rhamnus Purshiana 1X Santoninum 6X 8X Scrophularia Nodosa 3X Senna 1X Sulphur 6C 9C Tanacetum Vulgare 4X 8X Teucrium Marum 2X 6X 8X

Warnings:

WARNINGS SECTION

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults & children ages 12 years and over: Take 10 drops under the tongue 3 times a day, or as directed by your healthcare professional. Consult a physician for use in children under 12 years of age.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

alcohol (20% by volume), glycerin, distilled water

OTC - QUESTIONS SECTION

OTC - QUESTIONS SECTION

Distributed by Apex Energetics. Questions? 16592 Hale Ave., Irvine, CA 92606, USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FUTUREPLEX® N10 ANTITOX® PARAKLENZ™ Homeopathic Formula Digestive Discomfort* Diarrhea* Skin Rash* 1 fl oz (30 mL) Alcohol 20% by Volume

Source Document#

Source XML