Label: CLARIFYING BACNE- salicylic acid spray
- NDC Code(s): 68479-782-02
- Packager: Dermalogica, LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated September 26, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
Do not use
- In or near eyes. If contact occurs, flush thoroughly with water.
- If irritation develops, discontinue use.
- Contents under pressure
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Directions
- Clean the skin thoroughly before applying this product.
- Cover the entire affected area with a thin layer one to three times daily.
- Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
- If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
- Hold the spray about a foot and a half away from your body and mist onto clean, dry skin.
- Let it sink into skin for 30-60 seconds.
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Inactive ingredients
Water/Aqua/Eau, Hamamelis Virginiana (Witch Hazel) Water, Isoceteth-20, Ethoxydiglycol, Hexylene Glycol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Citrus Limon (Lemon) Peel Oil, Cymbopogon Schoenanthus Oil, Argania Spinosa Kernel Oil, Citrus Reticulata (Tangerine) Leaf Oil, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Porphyra Umbilicalis Extract, Serenoa Serrulata Fruit Extract, Sesamum Indicum (Sesame) Seed Oil, Butylene Glycol, Tocopherol, Beta-Sitosterol, Ethylhexylglycerin, Polysorbate 20, Sodium Hydroxide, Disodium EDTA, Phenoxyethanol, Benzoic Acid, Limonene, Linalool, Citral, Geraniol, Citronellol, Coumarin.
- Questions or comments
- PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label
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INGREDIENTS AND APPEARANCE
CLARIFYING BACNE
salicylic acid sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68479-782 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid 1 g in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V) Isoceteth-20 (UNII: O020065R7Z) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) Hexylene Glycol (UNII: KEH0A3F75J) Phenoxyethanol (UNII: HIE492ZZ3T) Polysorbate 20 (UNII: 7T1F30V5YH) ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B) Sodium Hydroxide (UNII: 55X04QC32I) TEA TREE OIL (UNII: VIF565UC2G) Ethylhexylglycerin (UNII: 147D247K3P) LAVENDER OIL (UNII: ZBP1YXW0H8) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) Butylene Glycol (UNII: 3XUS85K0RA) LEMON OIL, DISTILLED (UNII: ET5GD00TRP) Cymbopogon Schoenanthus Oil (UNII: XE7K568ILO) ARGAN OIL (UNII: 4V59G5UW9X) Benzoic Acid (UNII: 8SKN0B0MIM) CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T) SESAME OIL (UNII: QX10HYY4QV) GREEN TEA LEAF (UNII: W2ZU1RY8B0) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) PORPHYRA UMBILICALIS (UNII: 14AN0J70WO) Tocopherol (UNII: R0ZB2556P8) .BETA.-SITOSTEROL (UNII: S347WMO6M4) SAW PALMETTO (UNII: J7WWH9M8QS) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) CITRAL (UNII: T7EU0O9VPP) Geraniol (UNII: L837108USY) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) Coumarin (UNII: A4VZ22K1WT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68479-782-02 177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 10/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M006 10/01/2023 Labeler - Dermalogica, LLC. (177698560) Establishment Name Address ID/FEI Business Operations Bell International 967781555 MANUFACTURE(68479-782)
