Stye Symptom Formula
FDA Label NDC 57955-7225

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 Stye Symptom Formula (NDC 57955-7225). 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 otc - active ingredient, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Drug Facts

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

HPUS active ingredients: Apis mellifica, Calcarea picrata, graphites, Hepar sulphuris calcareum, Juglans regia, Lycopodium clavatum, Pulsatilla, Silicea, Staphysagria, Sulphur, Thuja occidentalis.

Indications & Usage

Uses for temporary relief from symptoms of styes or hordeolums:

  • swollen eyelids
  • eyelid discomfort
  • redness
  • sensitivity to touch
  • inflammation
  • itching
  • stinging

Warnings

Warnings

  • Do not use in eyes - oral use only
  • Stop use and ask a doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, ask a healthcare professional before use.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.

Dosage & Administration

Directions:

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Adults: 3 sprays 3 times per day.
  • Children ages 2-12: 2 sprays 3 times per day.
  • Use additionally as needed, up to 6 times per day.

Other Safety Information

Other Information

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

Inactive Ingredient

Inactive Ingredients: Citric acid, potassium sorbate, purified water.

Otc - Purpose

Drug Facts

__________________________________________________________________________________________________________________

HPUS active ingredients                                                                    Purpose

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

Apis mellifica.............................................................................styes, stinging

Calcarea picrata.........................................................................boils

Graphites..................................................................................red, swollen, and dry eyelids

Hepar sulphuris calcareum..........................................................eye discomfort

Juglans regia.............................................................................small, red eruptions

Lycopodium clavatum.................................................................ulceration of eyelids

Pulsatilla...................................................................................itching

Silicea......................................................................................eyes tender to touch

Staphysagria.............................................................................recurrent styes, eye discomfort

Sulphur....................................................................................heat in eyes

Thuja occidentalis......................................................................dry and scaly eyelids

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