FDA.reportPublic FDA data

Ileocecal Valve Detox

Manufacturer
King Bio Inc.
Effective date
2016-04-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:07:44

Label at a glance#

ProductIleocecal Valve Detox
Active ingredientANTIMONY TRISULFIDE, ARSENIC TRIOXIDE, CINCHONA OFFICINALIS BARK, CITRULLUS COLOCYNTHIS FRUIT PULP, GAMBOGE, GENTIANA LUTEA ROOT, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM SULFATE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts​__________________________________________________________________________________________________________

HPUS active ingredients: Antimonium crudum, Arsenicum album, Cinchona officinalis, Colocynthis, Gambogia, Gentiana lutea, Magnesia phosphorica, Natrum sulphuricum, Nux vomica, Phosphorus. Equal volumes of each ingredient in 10X, 30X, LM1 potencies.

INDICATIONS & USAGE SECTION

Uses ​for temporary relief of: sensitivity, pain or pressure in lower right abdomen, bad breath, toxic taste in mouth, ringing in the ears.

Note: Consult a physician if abdominal pain is accompanied by fever or other potential symptoms of appendicitis.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

WARNINGS SECTION

Warnings

  • Stop use and ask your doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, ask a healthcare professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Ages 12 and up: 3 sprays 3 times per day.
  • Ages 2-12: 2 sprays 3 times per day.

OTHER SAFETY INFORMATION

Tamper resistant for your protection. Use only if seal is intact.

OTC - PURPOSE SECTION

Uses for temporary relief of: •sensitivity, pain or pressure in lower right abdomen •bad breath •toxic taste in mouth •ringing in the ears.

Note: Consult a physician if abdominal pain is accompanied by fever or other potential symptoms of appendicitis.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-6083-22020-01-31C16284748780-19d75b9d0-ceef-f424-e053-dadaa90a57ceIleocecal Valve Detox™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-6083-2Ileocecal Valve Detox59 mL in 1 BOTTLE, SPRAYLIQUID591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-6083ILEOCECAL VALVE DETOX (ANTIMONIUM CRUDUM, ARSENICUM ALBUM, CINCHONA OFFICINALIS, COLOCYNTHIS, GAMBOGIA, GENTIANA LUTEA, MAGNESIA PHOSPHORICA, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS) LIQUID [KING BIO INC.]1Legacy NDC, 1 package rows20160413_96754ddd-29f0-4a20-8bfe-bdecf1fefbb6.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57955-608357955-6083-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANTIMONY TRISULFIDEF79059A38UACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
CITRULLUS COLOCYNTHIS FRUIT PULP23H32AOH17ACTIB
GAMBOGE7556HJ7587ACTIB
GENTIANA LUTEA ROOTS72O3284MSACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB
SODIUM SULFATE0YPR65R21JACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORUS27YLU75U4WACTIB
WATER059QF0KO0RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
POTASSIUM SORBATE1VPU26JZZ4IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3c8d9493-58e9-48fe-b9af-91592b78451f96754ddd-29f0-4a20-8bfe-bdecf1fefbb62016-04-13WarningsExact identifier
spl id: 3c8d9493-58e9-48fe-b9af-91592b78451f
spl set id: 96754ddd-29f0-4a20-8bfe-bdecf1fefbb6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.