Quitacallos
FDA Label NDC 10095-006

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by World Perfumes, Inc for the product Quitacallos (NDC 10095-006). 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, otc - keep out of reach of children, indications & usage, dosage & administration, warnings, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

ACTIVE INGREDEINT: Salicylic Acid 17% (w/w)

Otc - Purpose

Corn & Callus Remover

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of the reach of children.

Indications & Usage

QuitaCallos

Removedor de Callos

Corn & Callus Remover

Salicylic Acid 17%

Dosage & Administration

Directions: Wash affected area and dry thoroughly. Brush on corn or callus only, not on healthy skin. Let dry. Repeat this procedure once or twice daily as needed for up to 14 days (until corn/callus is removed). You may also soak corn/callus in warm water for 5 minutes to assist in removal.

Warnings

Warnings: For external use only. Do not use this product on irritated skin, or on any area that is infected or reddened, if you are a diabetic, or if you have poor blood circulation. If discomfort persists, see your doctor or a podiatrist. Extremely flammable. Keep away from fire or flame. Cap bottle tightly and store at room temperature away from heat. If product gets into eye, flush with water for 15 minutes. Avoid inhaling vapors.

Inactive Ingredient

Inactive Ingredients: flexible collodion, isopropyl alcohol.

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