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MIZON ACENCE BLEMISH OUT PINK SPOT

Dosage form: solution
Ingredients: Salicylic Acid 0.15mg in 30mL
Labeler: MIZON CO., LTD.
NDC Code: 57718-060

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MIZON ACENCE BLEMISH OUT PINK SPOT 
salicylic acid solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57718-060
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (SALICYLIC ACID) Salicylic Acid0.15 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol 
Water 
Packaging
#Item CodePackage Description
1NDC:57718-060-0130 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D07/01/2015
Labeler - MIZON CO., LTD. (557815570)
Registrant - MIZON CO., LTD. (557815570)
Establishment
NameAddressID/FEIOperations
MIZON CO., LTD.557815570repack(57718-060)
Establishment
NameAddressID/FEIOperations
Coson Co., Ltd.689835593manufacture(57718-060)

Revised: 08/2015
 
MIZON CO., LTD.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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