Stalean
FDA Label NDC 57520-0190

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Apotheca Company for the product Stalean (NDC 57520-0190). 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, otc - purpose, warnings, dosage & administration, inactive ingredient, otc - questions, 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

Otc - Active Ingredient

Active Ingredients:  L Carnitine Tartrate 30X, 60X, L Isoleucine 30X, 60X, L Leucine 30X, 60X, L Valine 30X, 60X, Magnesia Phosphorica 30X, 60X, Pyridoxine 30X, 60X, Argentum Metallicum 60X, 100X, 200X, Calcarea Carbonica 60X, 100X, 200X, Mercurius Solubilis 60X, 100X, 200X, Natrum Sulphuricum 60X, 100X, 200X, Oleander 60X, 100X, 200X, Sabadilla 60X, 100X, 200X, Hypothalamus 6C, 12C, 30C, 100C, Dopamine 6C, 60C, 100C, 200C, Pancreas 6C, 60C, 100C, 200C, Serotonin 6C. 60C, 100C, 200C, Spleen 6C, 60C, 100C, 200C.

Otc - Purpose

Indications:  Supports weight loss, insulin resistance, food cravings and emotional eating.  Provides support before, during and after dieting.

Other helpful remedy; HCG Max


Warnings

WARNINGS:  As with any drug,if pregnant or breast-feeding; or under age 18;  consult a physician before use.   Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.  Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away.

Store in a cool, dry place after opening.

Dosage & Administration

DIRECTIONS:   Adults Only;  1 or 2 sprays daily under the tongue as needed or as directed by a health professional.

Inactive Ingredient

Inactive Ingredients:  Demineralized Water, 25% Ethanol, Cerato, Chestnut Bud, Gorse, Larch, Walnut, Wild Oat.

Otc - Questions

Formulated and Dist. by:

Weight Loss Products, LLC

St. Petersburg, FL 33707

www.STA-LEAN.com

1-202-239-2130

Package Label.Principal Display Panel

SUPPORTS LONG TERM WEIGHT LOSS

STA.LEAN

ORAL SPRAY

1 FL OZ / 30 ML

HOMEOPATHIC FORMULA

Stalean (Mm1)

Stalean (Mm1)

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