Cover FX Mattifying Primer Plus Acne Treatment

Manufacturer
Cover FX Skin Care Inc
Effective date
2018-11-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:57:26

Label at a glance#

ProductCover FX Mattifying Primer Plus Acne Treatment
Active ingredientSALICYLIC ACID
Label structure11 sections

Indications and uses

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

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 1%

PURPOSE

OTC - PURPOSE SECTION

Acne Treatment

USES

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

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

PRODUCT PACKAGING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COVER FX

MATTIFYING PRIMER +ACNE TREATMENT

mattifyingmattifying

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
251380salicylic acid 1 % Topical GelPSN1
251380salicylic acid 0.01 MG/MG Topical GelSCD1
251380salicylic acid 1 % Topical GelSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68327-073-01Cover FX Mattifying Primer Plus Acne Treatment1 in 1 CARTONGEL11
68327-073-01Cover FX Mattifying Primer Plus Acne Treatment30 mL in 1 TUBEGEL301
68327-073-02Cover FX Mattifying Primer Plus Acne Treatment15 mL in 1 TUBEGEL151
68327-073-03Cover FX Mattifying Primer Plus Acne Treatment5 mL in 1 TUBEGEL51
68327-073-03Cover FX Mattifying Primer Plus Acne Treatment1 in 1 CARTONGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68327-073COVER FX MATTIFYING PRIMER PLUS ACNE TREATMENT (SALICYLIC ACID) GEL [COVER FX SKIN CARE INC]1Current NDC, Legacy NDC, 5 package rows20181130_7bcf8a39-9c98-13bc-e053-2991aa0a3beb.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68327-07368327-073-01, 68327-073-02, 68327-073-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cover FX Mattifying Primer Plus Acne TreatmentSALICYLIC ACIDCover FX Skin Care Inc7bcf8a39-9c98-13bc-e053-2991aa0a3beb2018-11-29WarningsExact identifier
ndc (package): 68327-073-01
ndc (package): 68327-073-02
ndc (package): 68327-073-03
ndc (product): 68327-073
ndc11 (package): 68327007302
ndc11 (package): 68327007301
ndc11 (package): 68327007303
spl id: 6f90fc3d-7ba9-89be-e053-2991aa0a0533
spl set id: 7bcf8a39-9c98-13bc-e053-2991aa0a3beb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.