FDA.reportPublic FDA data

4TP - IV FOR INJECTION (82926-206)

Manufacturer
4TP LLC
Effective date
2022-10-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:52:29

Label at a glance#

Product4TP FOR INTRAVENOUS INFUSION ONLY
Active ingredientZINC IODIDE
Label structure9 sections

Indications and uses

Relieves respiratory difficulties and bronchial irritations (cough).

Dosage and administration

Note: The 4TP inhalation solution contained in the 60 mL bottle does not require dilution. The solution should be poured directly into the nebulizer as per the instructions below. Read complete instructions carefully before using EpiphaniQ. Pour 5ml of 4TP solution into the nebulizer reservoir through the appropriate opening. Gently swirl the nebulizer to mix the contents. Connect the nebulizer to the mouthpiece o...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

ZINCUM IODATUM 2X HPUS

PURPOSE

OTC - PURPOSE SECTION

TO TREAT RESPIRATORY DIFFICULTIES, COUGH AND PERTUSSIS

USES

INDICATIONS & USAGE SECTION

Relieves respiratory difficulties and bronchial irritations (cough).

WARNINGS

WARNINGS SECTION

When using this product

  • If pregnant or breast-feeding ask a healthcare professional before use
  • Children under 12: consult a doctor before use
  • Do not exceed recommended dosage
  • The use of this container by more than one person may spread infection
  • For your safety do not use if seal is broken

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Note: The 4TP inhalation solution contained in the 60 mL bottle does not require dilution. The solution should be poured directly into the nebulizer as per the instructions below. Read complete instructions carefully before using EpiphaniQ.

  1. Pour 5ml of 4TP solution into the nebulizer reservoir through the appropriate opening.
  2. Gently swirl the nebulizer to mix the contents. Connect the nebulizer to the mouthpiece or facemask.
  3. Connect the nebulizer to the compressor.
  4. Sit in a comfortable upright position. Place the mouthpiece in your mouth or wear the face mask. Turn the compressor on.
  5. Breathe as calmly, deeply and evenly as possible until no more mist is formed in the nebulizer chamber (about 5 to fifteen minutes).
  6. Clean the nebulizer (see manufacturer's instructions).

Other Information

OTHER SAFETY INFORMATION

Store at room temperature away from direct light. Does not require refrigeration.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

DMSO, WATER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_4TP_Nebulizer_60mL01b LBL_4TP_Nebulizer_60mL

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82926-20682926-206-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHYL SULFOXIDEYOW8V9698HIACT
WATER059QF0KO0RIACT
ZINC IODIDE762R7A0O0BACTIM

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
f66de3cd-caff-973e-e053-2995a90afa22ea3e2e50-923c-9990-e053-2995a90ab0a82023-03-08WarningsExact identifier
spl set id: ea3e2e50-923c-9990-e053-2995a90ab0a8

Reported adverse events (FAERS/openFDA)#

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