Label: ACNE TONER ACNE CLEARING SYSTEM- salicylic acid liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 49825-136-01, 49825-136-02, 49825-136-03, 49825-136-04 - Packager: Bioelements
- 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 November 23, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Water (Aqua, Eau), Glycerin, Hexylene Glycol, Pentylene Glycol, PEG-40 Hydrogenated Castor Oil, Trideceth-9, Vitis Vinifera (Grape) Fruit Extract, Honey (Mel) Extract (Miel Extrait de mile), Actinidia Chinensis (Kiwi) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Ananas Sativus (Pineapple) Furit Extract, Citrus Medica Limonum (Lemon) Fruit Extract, Citrus Aurantifolia (Lime) Fruit Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Citrus Grandis (Grapefruit) Fruit Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Tetrahexyldecyl Ascorbate, Citrus Grandis (Grapefruit) Peel Oil, Citrus Aurantium Dulcis (Orange) Oil, Lavandula Hybrida (Lavandin) Oil, Caprylic/Capric Triglyceride, Canarium Luzonicum Gum Nonvolatiles, Sodium Hydroxide, Ethylhexylglycerin, Phenoxyethanol
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACNE TONER ACNE CLEARING SYSTEM
salicylic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49825-136 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID .5 g in .5 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) HEXYLENE GLYCOL (UNII: KEH0A3F75J) PENTYLENE GLYCOL (UNII: 50C1307PZG) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) TRIDECETH-9 (UNII: X9HD79I514) WINE GRAPE (UNII: 3GOV20705G) HONEY (UNII: Y9H1V576FH) KIWI FRUIT (UNII: 71ES77LGJC) PAPAYA (UNII: KU94FIY6JB) PINEAPPLE (UNII: 2A88ZO081O) LEMON (UNII: 24RS0A988O) LIME (CITRUS) (UNII: 8CZS546954) LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P) PUMMELO (UNII: ET1TN5W71X) ORANGE (UNII: 5EVU04N5QU) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44) ORANGE OIL (UNII: AKN3KSD11B) LAVANDIN OIL (UNII: 9RES347CKG) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ELEMI (UNII: C13XI009KO) SODIUM HYDROXIDE (UNII: 55X04QC32I) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49825-136-02 1 in 1 BOX 04/10/2015 1 NDC:49825-136-01 88 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:49825-136-04 1 in 1 BOX 04/10/2015 2 NDC:49825-136-03 236 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358B 04/10/2015 Labeler - Bioelements (174813923) Registrant - Bioelements (174813923) Establishment Name Address ID/FEI Business Operations Cosmetic Enterprises 017701475 manufacture(49825-136)
