Goutflex Gout Symptom Formula
FDA Label NDC 69760-0001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nutra Vista Health Llc. for the product Goutflex Gout Symptom Formula (NDC 69760-0001). 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​__________________________________________________________________________________________________________

HPUS active ingredients                                                                            Purpose †

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

Ammonium phosphoricum, Belladonna, Colchicum autumnale, Formicum acidum, Fraxinus excelsior, Ledum palustre, Natrum carbonicum, Nux vomica, Urtica urens.

Indications & Usage

Uses for temporary relief of symptoms in toes, heels, feet, or joints: • discomforts • cramping • tender or itchy joints.

Warnings

Warnings

  • If symptoms persist or worsen, seek advice of a physician.
  • 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: 4 sprays 2 times per day. (approximately every 12 hours) Use additionally as needed, up to 3 times per day.

Other Safety Information

Other Information: This product is intended to complement, not replace, standard medical care.

This product has not been clinically tested. Homeopathic provings for each HPUS ingredient are found in various materia medicas referenced in the FDA Compliance Policy Guide.

Manufactured for: Nutra Vista Health, LLC. 3632 Land O Lakes Blvd 106-14 Land O Lakes, FL, 34639 Questions? Call 813.926.7903 www.goutflex.com

Inactive Ingredient

Inactive Ingredients:

Citric acid, potassium sorbate, pure water.

Otc - Purpose

Drug Facts

__________________________________________________________________________________________________________

HPUS active ingredients                                             Purpose †

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

Ammonium phosphoricum...........................inflammation of joints

Belladonna.................................................red and tender joints

Colchicum autumnale......................................sensitivity to touch

Formicum acidum...............................................joint discomfort

Fraxinus excelsior...................................foot-related discomforts

Ledum palustre...................................swelling of joints and toes

Natrum carbonicum...............................................tender joints

Nux vomica..................................................................itching

Urtica urens.....................................................joint discomfort

Package Label.Principal Display Panel

Image Description (Goutflex)

Image Description (Goutflex)

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