Label: COVER FX MATTIFYING PRIMER PLUS ACNE TREATMENT- salicylic acid gel
- NDC Code(s): 68327-073-01, 68327-073-02, 68327-073-03
- Packager: Cover FX Skin Care 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 November 29, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- When using this product
- Keep out of reach of children.
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DIRECTIONS
- Clean skin thoroughly before applying.
- Cover entire affected area with a thin layer 1 to 3 times daily.
- Because excessive drying of the skin may occur, start with 1 application, then gradually increase to 2 or 3 if needed or as directed by a doctor.
- If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
- OTHER INFORMATION
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INACTIVE INGREDIENTS
Cyclopentasiloxane, Salix Nigra (Willow) Bark Extract, Water/Eau, Dimethicone Crosspolymer, Butylene Glycol, Dimethicone/Vinyl Dimethicone Crosspolymer, Bis-PEG/PPG-14/14 Dimethicone, Vaccinium Myrtillus Fruit Extract, Glycerin, Dimethicone, Caprylic/Capric Triglyceride, Cetyl PEG/PPG-10/1 Dimethicone, Squalane, Phenyl Methicone, Saccharum Officinarum (Sugar Cane) Extract/Extrait de canne a sucre, Bisabolol, Caprylyl Glycol, Tocopherol, Dimethiconol, Phenoxyethanol, PEG-60 Almond Glycerides, Acer Saccharum (Sugar Maple) Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Enantia Chlorantha Bark Extract, Citrus Limon (Lemon) Fruit Extract, Phytosphingosine, Tetrahexyldecyl Ascorbate, Ethyl Linoleate, Ethyl Linolenate, Ethyl Oleate, Carbomer, Silica, Polysorbate 20, Oleanolic Acid, Nordihydroguaiaretic Acid, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7
- COMPANY INFORMATION
- PRODUCT PACKAGING
-
INGREDIENTS AND APPEARANCE
COVER FX MATTIFYING PRIMER PLUS ACNE TREATMENT
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68327-073 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 CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) SALIX NIGRA BARK (UNII: QU52J3A5B3) WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE) BILBERRY (UNII: 9P2U39H18W) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) SQUALANE (UNII: GW89575KF9) PHENYL METHICONE (500 CST) (UNII: 5T0F958X3Z) SUGARCANE (UNII: 81H2R5AOH3) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TOCOPHEROL (UNII: R0ZB2556P8) DIMETHICONOL (40 CST) (UNII: 343C7U75XW) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F) ACER SACCHARUM BARK/SAP (UNII: Z120VL0KAC) ORANGE (UNII: 5EVU04N5QU) ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A) LEMON (UNII: 24RS0A988O) PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) ETHYL LINOLEATE (UNII: MJ2YTT4J8M) ETHYL LINOLENATE (UNII: T54Y8H042V) ETHYL OLEATE (UNII: Z2Z439864Y) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYSORBATE 20 (UNII: 7T1F30V5YH) OLEANOLIC ACID (UNII: 6SMK8R7TGJ) MASOPROCOL (UNII: 7BO8G1BYQU) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68327-073-01 1 in 1 CARTON 11/29/2018 1 30 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:68327-073-02 15 mL in 1 TUBE; Type 0: Not a Combination Product 11/29/2018 3 NDC:68327-073-03 1 in 1 CARTON 11/29/2018 3 5 mL in 1 TUBE; 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 11/29/2018 Labeler - Cover FX Skin Care Inc (202908021) Registrant - Cover FX Skin Care Inc (202908021)
