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ACENCE TEA TREE TOCK BLEMISH SPOT

Dosage form: solution
Ingredients: Salicylic Acid 22.5mg in 15mL
Labeler: MIZON CO., LTD.
NDC Code: 57718-090

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 0.15%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Alcohol, Polyvinyl Alcohol, Butylene Glycol, Propylene Glycol, Peg-60 Hydrogenated Castor Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Triethanolamine, Melaleuca Alternifolia(Tea Tree) Leaf Oil, Ethylhexylglycerin, Caprylyl Glycol, Menthol, Melaleuca Alternifolia(Tea Tree) Leaf Extract, Tropolone, Disodium Edta, Cordyceps Sinensis Extract, Hamamelis Virginiana(Witch Hazel) Leaf Water, Glycerin, Coptis Chinensis Root Extract, Citrus Grandis(Grapefruit) Peel Oil, Citrus Medica Limonum(Lemon) Fruit Extract, Pinus Pinaster Bark/Bud Extract, Centella Asiatica Extract, Hedera Helix(Ivy) Extract, Sodium Hyaluronate, Propolis Extract, Beta-Glucan

PURPOSE

Purpose: Antiacne

WARNINGS

Warnings: 1. If following symptoms occur, stop use and consult a doctor: red spots, swelling, itching, irritation, or symptoms where product has been applied under direct sunlight. 2. Do not use on scarred skin or if you have dermatitis or eczema. 3. Keep the cap closed on this product. 4. Keep away from direct sunlight or heat. 5. Keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Indications & usage

Indications & usage: Place the tip of the product against the blemish you would like to treat and apply the gel evenly over the blemish. Squeeze the tube gently if the gel is not dispensing.

DOSAGE & ADMINISTRATION

Dosage & administration: Apply a small amount to skin to treat blemishes and trouble spots as needed.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ACENCE TEA TREE TOCK BLEMISH SPOT 
salicylic acid solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57718-090
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (SALICYLIC ACID) Salicylic Acid22.5 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Alcohol 
Packaging
#Item CodePackage Description
1NDC:57718-090-0115 mL in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D12/01/2015
Labeler - MIZON CO., LTD. (557815570)
Registrant - MIZON CO., LTD. (557815570)
Establishment
NameAddressID/FEIOperations
MIZON CO., LTD.557815570repack(57718-090)
Establishment
NameAddressID/FEIOperations
Coson Co., Ltd.689835593manufacture(57718-090)

Revised: 01/2016
 
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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