MIZON ACENCE BLEMISH OUT PINK SPOT- salicylic acid solution 
MIZON CO., LTD.

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.

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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

Image of carton

MIZON ACENCE BLEMISH OUT PINK SPOT 
salicylic acid solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57718-060
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) Salicylic Acid0.15 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol (UNII: 3K9958V90M)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57718-060-0130 mL in 1 CARTON; Type 0: Not a Combination Product
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/FEIBusiness Operations
MIZON CO., LTD.557815570repack(57718-060)
Establishment
NameAddressID/FEIBusiness Operations
Coson Co., Ltd.689835593manufacture(57718-060)

Revised: 8/2015
Document Id: 22532d46-252a-45b6-b5b9-b95d00908b0b
Set id: 6c608fab-615e-4e58-baf3-cbc936dd8702
Version: 1
Effective Time: 20150825
 
MIZON CO., LTD.