COVER FX MATTIFYING PRIMER PLUS ACNE TREATMENT- salicylic acid gel 
Cover FX Skin Care Inc

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.

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Cover FX Mattifying Primer Plus Acne Treatment

ACTIVE INGREDIENT

Salicylic Acid 1%

PURPOSE

Acne Treatment

USES

For the treatment of acne. Helps treat acne pimples and allows skin to heal.

WARNINGS

For external use only

When using this product

skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center right away.

DIRECTIONS

OTHER INFORMATION

Report serious adverse event to 575 Fifth Ave 14th Floor New York, NY 10017

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

Dist. By: Cover FX Skin Care Inc. Toronto Ontario Canada M3J 2W8
Made in Canada
www.coverfx.com

PRODUCT PACKAGING

COVER FX

MATTIFYING PRIMER +ACNE TREATMENT

mattifying

COVER FX MATTIFYING PRIMER PLUS ACNE TREATMENT 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68327-073
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68327-073-011 in 1 CARTON11/29/2018
130 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:68327-073-0215 mL in 1 TUBE; Type 0: Not a Combination Product11/29/2018
3NDC:68327-073-031 in 1 CARTON11/29/2018
35 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D11/29/2018
Labeler - Cover FX Skin Care Inc (202908021)
Registrant - Cover FX Skin Care Inc (202908021)

Revised: 11/2018
Document Id: 6f90fc3d-7ba9-89be-e053-2991aa0a0533
Set id: 7bcf8a39-9c98-13bc-e053-2991aa0a3beb
Version: 1
Effective Time: 20181129
 
Cover FX Skin Care Inc