Label: ACENCE TEA TREE TOCK BLEMISH SPOT- salicylic acid solution
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Contains inactivated NDC Code(s)
NDC Code(s): 57718-090-01 - Packager: MIZON CO., LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 22, 2016
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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
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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
- Indications & usage
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACENCE TEA TREE TOCK BLEMISH SPOT
salicylic acid solutionProduct 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)
