Active Ingredients Section
SALICYLIC ACID 1%
Clearprep Fx
FDA Label NDC 68327-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cover Fx Skin Care, Inc. for the product Clearprep Fx (NDC 68327-006). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients section, purpose section, indications and uses section, warning section, caution section, report adverse section, directions section, inactive ingredient section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose Section
MATTE FOUNDATION PRIMER AND ANTI-ACNE TREATMENT GEL
Indications And Uses Section
USE: HELPS TREAT ACNE PIMPLES AND ALLOWS SKIN TO HEAL.
Warning Section
WARNINGS: FOR EXTERNAL USE ONLY. USING OTHER TOPICAL ACNE PRODUCTS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE PRODUCT SHOULD BE USED UNLESS DIRECTED BY A HEALTH CARE PRACTITIONER.
THIS PRODUCT CONTAINS AN ALPHAHYDROXY ACID (AHA) THAT MAY INCREASE YOUR SKINS SENSITIVITY TO THE SUN AND PARTICULARLY THE POSSIBILITY OF SUNBURN. PLEASE LIMIT SUN EXPOSURE AND APPLY SUNBURN PROTECTANT WHILE USING THIS PRODUCT AND FOR A WEEK AFTERWARDS.
DO NOT USE IF TUBE SEAL HAS BEEN TAMPERED WITH.
Caution Section
CAUTION: DISCONTINUE USE IF SKIN IRRITATION DEVELOPS OR INCREASES. IF IRRITATION PERSISTS, CONTACT A HEALTH CARE PRACTITIONER. AVOID CONTACT WITH THE EYES; IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.
Report Adverse Section
YOU MAY REPORT A SERIOUS ADVERSE AFFECT FROM THIS PRODUCT TO (USA) COVER FX 33 ELM STREET, SUITE 377, CHAMPLAIN, NY 2919 (CANADA) COVER FX 1681 FLINT RD, TORONTO, ON M3J 2W8
Directions Section
PRIME YOUR SIN WITH THIS LIGHTWEIGHT GEL PRIMER, TO IMPROVE BLENDING AND WEAR. DERMAVEIL BLURS THE APPEARANCE OF PORES AND FINE LINES. AFRICAN TREE BARK EXTRACT NATURALLY HELPS REDUCE SHINE. EXPERIENCE A BLEND OF BOTANICAL EXTRACTS THAT HELP PROMOTE SMOOTHER LOOKING SKIN.
DIRECTIONS: CLEANSE SKIN THOROUGHLY BEFORE APPLYING THE PRODUCT. APPLY PRODUCT TO AFFECTED AREAS ONE TO THREE TIMES DAILY OR AS DIRECTED BY A HEALTH CARE PRACTITIONER.
Inactive Ingredient Section
INACTIVE INGREDIENTS: CYCLOPENTASILOXANE AQUA DIMETHICONE CROSSPOLYMER BUTYLENE GLYCOL DIMETHICONE SALIX NIGRA (WILLOW) BARK EXTRACT BIS-PEG/PPG-14/14 DIMETHICONE GLYCERIN SQUALANE VACCINIUM MYRTILLUS (BILBERRY) FRUIT EXTRACT CAPRYLIC/CAPRIC TRIGLYCERIDE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER CETYL PEG/PPG-10/1 DIMETHICONE POLYMETHYLSILSESQUIOXANE SACCHARUM OFFICINARUM (SUGER CANE) EXTRACT PHENYL METHICONE BISABOLOL HYDROLYZED MILK PROTEIN TOCOPHERYL ACETATE DIMETHICONOL PEG-60 ALMOND GLYCERIDES PROPYLENE GLYCOL CITRUS AURANTIUM DULCIS (ORANGE) FRUIT EXTRACT CITRUS MEDICA LIMONUM (LEMON) FRUIT EXTRACT CAPRYLYL GLYCOL BENZYL ALCOHOL SILICA ENANTIA CHLORANTHA BARK EXTRACT LINOLEIC ACID LINOLENIC ACID ACER SACCHARUM (SUGAR MAPLE) EXTRACT TETRAHEXYLDECYL ASCORBATE BENZOIC ACID CARBOMER SORBIC ACID RETINYL PALMITATE POLYSORBATE 20 CITRUS AURANTIUM (NEROLI) OIL OLEANOLIC ACID NORDIHYDROGUAIARECTIC ACID PALMITOYL OLIGOPEPTIDE PALMITOYL TETRAPEPTIDE-7
Keep Out Of Reach Of Children Section
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Label Section
CLEARPREPFX MATTE FOUNDATION PRIMER AND ANTI-ACNE TREATMENT GEL
CRUELTY FREE SUSTAINABLE FORESTRY INITIATIVE CERTIFIED CHAIN OF CUSTODY WWW.SIFPROGRAM.ORG
COVER FX DIST. BY/PAR COVER FX SKIN CARE INC. TORONTO, ONTARIO CANADA M3J 2W8. LONDON W1V 2LD
DERMATOLOGISTS FIRST CHOICE
Clearprep Fx Product Label (Coverfx Clearprepfx)
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