CLEARPREP FX- salicylic acid gel

ClearPrep FX by

Drug Labeling and Warnings

ClearPrep FX 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 Ingredients Section

SALICYLIC ACID 1%

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

INGREDIENTS AND APPEARANCE

CLEARPREP FX 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68327-006
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)
WATER (UNII: 059QF0KO0R)
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
SALIX NIGRA BARK (UNII: QU52J3A5B3)
GLYCERIN (UNII: PDC6A3C0OX)
SQUALANE (UNII: GW89575KF9)
BILBERRY (UNII: 9P2U39H18W)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
SUGARCANE (UNII: 81H2R5AOH3)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
LEVOMENOL (UNII: 24WE03BX2T)
CASEIN (UNII: 48268V50D5)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIMETHICONOL (40 CST) (UNII: 343C7U75XW)
PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ORANGE (UNII: 5EVU04N5QU)
LEMON (UNII: 24RS0A988O)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
LINOLENIC ACID (UNII: 0RBV727H71)
ACER SACCHARUM BARK/SAP (UNII: Z120VL0KAC)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
BENZOIC ACID (UNII: 8SKN0B0MIM)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
SORBIC ACID (UNII: X045WJ989B)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
MASOPROCOL (UNII: 7BO8G1BYQU)
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68327-006-01	30 mL in 1 TUBE
2	NDC: 68327-006-02	15 mL in 1 TUBE
3	NDC: 68327-006-03	7 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	07/01/2011

Labeler - Cover FX Skin Care, Inc. (202908021)

Registrant - Cover FX Skin Care, Inc. (202908021)