Smoke Control
FDA Label NDC 57955-5080

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by King Bio Inc. for the product Smoke Control (NDC 57955-5080). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, inactive ingredient, dosage and administration, purpose, warnings, keep out of reach of children, indications and usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

HPUS active ingredients

Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.

Arsenicum album

Caladium seguinum

Carbolicum acidum

Daphne indica

Eugenia jambosa

Kali phosphoricum

Lobelia inflata

Nicotinum

Nux vomica

Plantago major

Saccharum officinale

Staphysagria

Tabacum

Thuja occidentalis

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Inactive Ingredient

Inactive ingredients

Bio-Energetically Enhanced taste-free, pure water base

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Dosage And Administration

Directions Initially, depress pump until primed. Hold close to mouth and spray one dose directly into mouth.

Adult Dose- 3 pump sprays 3 times per day. Use additionally as needed.

Children 2-12 years- 2 pump sprays 3 times per day. Use additionally as needed.

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Purpose

HPUS active ingredients                        Purpose

Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.

Arsenicum album...........................................toxic effects of ingested substances

Caladium seguinum........................................headache, tobacco craving

Carbolicum acidum........................................craving for stimulants

Daphne indica................................................tobacco craving

Eugenia jambosa...........................................nausea, headache

Kali phosphoricum.........................................anxiety, restlessness

Lobelia inflata................................................shortness of breath

Nicotinum.....................................................poor concentration

Nux vomica..................................................irritability

Plantago major.............................................insomnia

Saccharum officinale...................................nutritional deficiency

Staphysagria...............................................acute cravings, nervousness

Tabacum.....................................................tightness in chest, fatigue

Thuja occidentalis........................................dry and painful cough

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Warnings

If symptoms persist or worsen, seek advice of physician. If pregnant or nursing, take only on advice of a healthcare professional. Keep out of reach of children.

Other information

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

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Keep Out Of Reach Of Children

Keep out of reach of children

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Indications And Usage

Uses for temporary relief of symptoms:

  • tobacco cravings (smoke and chew)
  • headache
  • shortness of breath
  • cough
  • nervousness
  • tightness in chest
  • irritability
  • restlessness
  • insomnia
  • craving for stimulants
  • nausea
  • toxic effects of ingested substances
  • anxiety
  • poor concentration
    • as per various homeopathic Materia Medicas


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Package Label.Principal Display Panel


Image Of Carton Label (Smoke)

Image Of Carton Label (Smoke)



King Bio Inc.
3 Westside Drive
Asheville, NC 28806
www.kingbio.com

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