COVER FX MATTIFYING PRIMER WITH ANTI-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 with Anti-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 eyes. Rinse with water to remove.

Stop use and ask a doctor if

excessive skin irritation develops or increases.

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.

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

OTHER

Do not use if tube seal has been tampered with.

PRODUCT PACKAGING

MM1

COVER FX MATTIFYING PRIMER WITH ANTI-ACNE TREATMENT
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68327-040
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68327-040-01	30 mL in 1 TUBE; Type 0: Not a Combination Product	03/01/2015	04/30/2021
2	NDC:68327-040-02	15 mL in 1 TUBE; Type 0: Not a Combination Product	03/01/2015	11/30/2020
3	NDC:68327-040-03	5 mL in 1 TUBE; Type 0: Not a Combination Product	03/01/2015	02/28/2021
4	NDC:68327-040-04	1.5 mL in 1 PACKET; Type 0: Not a Combination Product	03/01/2015	01/31/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	03/01/2015	04/30/2021

Labeler - Cover FX Skin Care Inc (202908021)

Registrant - Cover FX Skin Care Inc (202908021)

Name	Address	ID/FEI	Business Operations
Establishment
CSR Cosmetic Solutions Inc.		243501959	manufacture(68327-040)

Revised: 12/2018

Document Id: 7d39b366-ca63-b094-e053-2991aa0a1641

Set id: 57ada11e-537f-46f9-ab23-1fb3cf3da1c1

Version: 3

Effective Time: 20181217

Cover FX Skin Care Inc