ACENCE TEA TREE TOCK BLEMISH SPOT- salicylic acid solution

ACENCE TEA TREE TOCK BLEMISH SPOT by

Drug Labeling and Warnings

ACENCE TEA TREE TOCK BLEMISH SPOT by is a Otc medication manufactured, distributed, or labeled by MIZON CO., LTD., Coson Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ACENCE TEA TREE TOCK BLEMISH SPOT 
salicylic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57718-090
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	Salicylic Acid	22.5 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Alcohol (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57718-090-01	15 mL in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	12/01/2015

Labeler - MIZON CO., LTD. (557815570)

Registrant - MIZON CO., LTD. (557815570)

Establishment
Name	Address	ID/FEI	Business Operations
MIZON CO., LTD.		557815570	repack(57718-090)

Establishment
Name	Address	ID/FEI	Business Operations
Coson Co., Ltd.		689835593	manufacture(57718-090)