COVER FX MATTIFYING PRIMER PLUS ACNE TREATMENT- salicylic acid gel

Cover FX Mattifying Primer Plus Acne Treatment by

Drug Labeling and Warnings

Cover FX Mattifying Primer Plus Acne Treatment by is a Otc medication manufactured, distributed, or labeled by Cover FX Skin Care Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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

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

INGREDIENTS AND APPEARANCE

COVER FX MATTIFYING PRIMER PLUS ACNE TREATMENT 
salicylic acid gel

Product 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)