Label: OVERNIGHT CLEARING- salicylic acid gel
- NDC Code(s): 68479-706-00, 68479-706-01, 68479-706-02
- Packager: Dermalogica, Inc.
- 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 December 4, 2017
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Indications
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Warnings
For external use only.
- Directions
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Inactive ingredients
Water (Aqua), PEG-32, Butylene Glycol, Salicylic Acid, PVM/MA Decadiene Crosspolymer, Polysorbate 20, Glycerin, PEG-60 Almond Glycerides, Mahonia Aquifolium Root Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Camellia Oleifera Leaf Extract, Spiraea Ulmaria Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Crithmum Maritimum Extract, Yeast Extract, Hydrogenated Vegetable Oil, Sodium Hyaluronate, Biotin, Panthenol, Caffeine, Niacinamide, Dipotassium Glycyrrhizate, Camphor, 10-Hydroxydecanoic Acid, Sebacic Acid, 1,10-Decanediol, Nordihydroquaiaretic Acid, Oleanolic Acid, Xanthan Gum, Carbomer, PEG-40 Hydrogenated Castor Oil, Ammonium Glycyrrhizate, Zinc Gluconate, Zinc Acetate, Sodium Hydroxide, Caprylic/Capric Triglyceride, Chlorphenesin, Caprylyl Glycol, Phenoxyethanol, Limonene, Linalool, Geraniol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Cymbopogon Martini Oil, Mentha Piperita (Peppermint) Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Limon (Lemon) Peel Oil, Foeniculum Vulgare (Fennel) Oil, Mentha Viridis (Spearmint) Leaf Oil, Pelargonium Graveolens Flower Oil, Eucalyptus Globulus Leaf Oil, Zingiber Officinale (Ginger) Root Oil, Artemisia Vulgaris Oil, Litsea Cubeba Fruit Oil, Piper Nigrum (Pepper) Seed Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Ocimum Basilicum (Basil) Oil, Cymbopogon Nardus (Citronella) Oil, Cinnamomum Zeylanicum Bark Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Salvia Officinalis (Sage) Oil, Thymus Vulgaris (Thyme) Oil.
- Questions or comments
- PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
OVERNIGHT CLEARING
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68479-706 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Polyethylene Glycol 1500 (UNII: 1212Z7S33A) Butylene Glycol (UNII: 3XUS85K0RA) Polysorbate 20 (UNII: 7T1F30V5YH) Glycerin (UNII: PDC6A3C0OX) PEG-60 Almond Glycerides (UNII: 4Y0E651N0F) BERBERIS AQUIFOLIUM ROOT (UNII: 746TB9VNDP) Rosemary (UNII: IJ67X351P9) Camellia Oleifera Leaf (UNII: 5077EL0C60) Filipendula Ulmaria Root (UNII: 997724QNDS) Horse Chestnut (UNII: 3C18L6RJAZ) Crithmum Maritimum (UNII: J7IHY79BKY) Yeast, Unspecified (UNII: 3NY3SM6B8U) Hyaluronate Sodium (UNII: YSE9PPT4TH) Biotin (UNII: 6SO6U10H04) Panthenol (UNII: WV9CM0O67Z) Caffeine (UNII: 3G6A5W338E) Niacinamide (UNII: 25X51I8RD4) Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX) Camphor (Synthetic) (UNII: 5TJD82A1ET) 10-Hydroxydecanoic Acid (UNII: NP03XO416B) Sebacic Acid (UNII: 97AN39ICTC) 1,10-Decanediol (UNII: 5I577UDK52) Masoprocol (UNII: 7BO8G1BYQU) Oleanolic Acid (UNII: 6SMK8R7TGJ) Xanthan Gum (UNII: TTV12P4NEE) Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E) Polyoxyl 40 Hydrogenated Castor Oil (UNII: 7YC686GQ8F) Ammonium Glycyrrhizate (UNII: 3VRD35U26C) Zinc Gluconate (UNII: U6WSN5SQ1Z) Zinc Acetate (UNII: FM5526K07A) Sodium Hydroxide (UNII: 55X04QC32I) Medium-Chain Triglycerides (UNII: C9H2L21V7U) Chlorphenesin (UNII: I670DAL4SZ) Caprylyl Glycol (UNII: 00YIU5438U) Phenoxyethanol (UNII: HIE492ZZ3T) Tea Tree Oil (UNII: VIF565UC2G) Rosemary Oil (UNII: 8LGU7VM393) Palmarosa Oil (UNII: 0J3G3O53ST) Peppermint Oil (UNII: AV092KU4JH) Citrus Maxima Fruit Rind Oil (UNII: 8U3877WD44) Lemon Oil (UNII: I9GRO824LL) Fennel Oil (UNII: 59AAO5F6HT) Spearmint Oil (UNII: C3M81465G5) Pelargonium Graveolens Flower Oil (UNII: 3K0J1S7QGC) Eucalyptus Oil (UNII: 2R04ONI662) Ginger Oil (UNII: SAS9Z1SVUK) Artemisia Vulgaris Top Oil (UNII: 72Q967Y48V) Litsea Oil (UNII: 2XIW34BN6O) White Pepper Oil (UNII: 2AM83DL9FV) Nutmeg Oil (UNII: Z1CLM48948) Basil Oil (UNII: Z129UMU8LE) Citronella Oil (UNII: QYO8Q067D0) Cinnamon Bark Oil (UNII: XE54U569EC) Orange Oil (UNII: AKN3KSD11B) Lavender Oil (UNII: ZBP1YXW0H8) Sage Oil (UNII: U27K0H1H2O) Thyme Oil (UNII: 2UK410MY6B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68479-706-02 1 in 1 CARTON 05/01/2007 1 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:68479-706-01 14 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2007 3 NDC:68479-706-00 2 mL in 1 POUCH; Type 0: Not a Combination Product 05/01/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part358H 05/01/2007 Labeler - Dermalogica, Inc. (177698560) Establishment Name Address ID/FEI Business Operations McKenna 090631412 MANUFACTURE(68479-706) Establishment Name Address ID/FEI Business Operations Diamond Wipes 161104729 MANUFACTURE(68479-706)
