Mizon Acence Blemish Out Pink Spot
FDA Label NDC 57718-060

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mizon Co., Ltd. for the product Mizon Acence Blemish Out Pink Spot (NDC 57718-060). 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, purpose, warnings, keep out of reach of children, directions for use, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Active Ingredient: Salicylic Acid 0.5%

Inactive Ingredient

Inactive Ingredients: Alcohol, Water, Calamine, Glycerin, Titanium Dioxide(CI77891), Glycolic Acid, Dimethyl Sulfone, Camphor, Peg-60 Hydrogenated Castor Oil, Rubus Idaeus(Raspberry) Fruit Extract, Propylene Glycol, Butylene Glycol, Coptis Chinensis Root Extract, Portulaca Oleracea Extract, Vaccinium Myrtillus Fruit/Leaf Extract, Saccharum Officinarum(Sugar Cane) Extract, Melaleuca Alternifolia(Tea Tree) Leaf Oil, Citrus Medica Limonum(Lemon) Fruit Extract, Citrus Aurantium Dulcis(Orange) Fruit Extract, Acer Saccharum(Sugar Maple) Extract, Pinus Pinaster Bark/Bud Extract, Hedera Helix(Ivy) Extract, Citrus Grandis(Grapefruit) Peel Oil

Purpose

Purpose: Blemish Treatment

Warnings

Warnings: 1. For external use only. 2. Avoid contact with eyes and mouth. 3. Discontinue use if signs of irritation or rashes appear. 4. Replace the cap after use. 5. If ingestion occurs, give victim water and seek medical attention.

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Directions For Use

Directions for use: Cleanse face thoroughly using face wash. Without shaking, use a cotton swab to dip to the bottom and apply directly to only blemishes and trouble spots overnight. Wash off with face wash the following morning.

Dosage & Administration

Dosage & Administration: Use on blemishes or pimples once daily. If excessive dryness or irritation occurs, discontinue use and consult your doctor.

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