Label: CLEAR DAYS AHEAD OIL-FREE SALICYLIC ACID ACNE TREATMENT AND MOISTURIZER- salicylic acid cream
- NDC Code(s): 50184-1010-1, 50184-1010-2
- Packager: Philosophy 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 January 24, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Indications
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Warnings
For external use only
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Directions
- cleanse skin thoroughly before applying medication. cover the entire affected area with a thin layer 1-3 times daily
- because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2-3 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.
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Inactive ingredients
water, dimethicone, polysilicone-11, butylene glycol, acacia decurrens/jojoba/sunflower seed wax/polyglyceryl-3 esters, caprylic/capric triglyceride, sodium acrylates copolymer, squalane, lecithin, oligopeptide- 10, tocopheryl acetate, trimethylpentanediol/adipic acid copolymer, octyldodecyl neopentanoate, ceteareth-20, cetearyl alcohol, polysorbate 60, ppg-12/smdi copolymer, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, ethoxydiglycol, sodium hydroxide, disodium edta, o-cymen-5-ol.
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- Principal Display Panel - 60 ml Sleeve Label
- Principal Display Panel - 60 ml Box Label
- Principal Display Panel - 60 ml Bottle Label
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INGREDIENTS AND APPEARANCE
CLEAR DAYS AHEAD OIL-FREE SALICYLIC ACID ACNE TREATMENT AND MOISTURIZER
salicylic acid creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50184-1010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.6 g in 60 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SQUALANE (UNII: GW89575KF9) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYSORBATE 60 (UNII: CAL22UVI4M) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) SODIUM HYDROXIDE (UNII: 55X04QC32I) EDETATE DISODIUM (UNII: 7FLD91C86K) O-CYMEN-5-OL (UNII: H41B6Q1I9L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50184-1010-1 60 mL in 1 TUBE; Type 0: Not a Combination Product 04/01/2012 2 NDC:50184-1010-2 60 mL in 1 BOX; Type 0: Not a Combination Product 04/01/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 04/01/2012 Labeler - Philosophy Inc. (948102256) Registrant - Coty US LLC (039056361) Establishment Name Address ID/FEI Business Operations Process Technologies and Packaging Inc. 809172885 manufacture(50184-1010)