COVER FX BLEMISH TREATMENT PRIMER- 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.

----------

Drug Facts
Active ingredient

Salicylic acid 0.5% w/w

Purpose

Acne treatment

Keep out of reach of children

Keep out of reach of children.

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

Use

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, use only 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.

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 dotor.

INACTIVE INGREDIENTS

Water/Eau, Butylene Glycol, Polysorbate 20, Hydroxyethylcellulose, Glycereth-18 Ethylhexanoate, Glycereth-18, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Algae Extract, Aloe Barbadensis Leaf Extract, Macrocystis Pyrifera (Kelp) Extract, Helianthus Annuuss (Sunflower) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Citrus Limon (Lemon) Peel Oil, Zingiber Officinalis (Ginger) Root Extract, Thymus Vulgaris(Thyme) Leaf Oil, Quillaja Saponaria Bark Extract, Disodium Lauriminodipropioate Tocopheryl Phosphate, Carrageenan,Glycerin, Panthenol, Ethylhexylglycerin, Lactic Acid, Sodium Hydroxide, Disodium EDTA, Tetrahexyldecyl Ascorbate, Chlorphenesin, Phenoxyethanol, Caprylyl Glycol

Cover Fx Blemish Treatment Primer product label

COVER l FX

BLEMISH TREATMENT PRIMER

ANTI-IMPERFECTIONS

with salicylic acid

15 mL/0.5FL OZ e

CLINICALLY TESTED. PARABEN, FRAGRANCE, GLUTEN, MINERAL OIL, AND TALC FREE VEGAN.

THIS SMOOTHING AND SOOTHING PRIMER HELPS CONCEAL WEAR, SO IMPERFECTIONS ARE DISGUISED LONGER. IT SHELTERS BLEMISHES, ALLOWING THEM TO BREATHE UNDERNEATH MAKEUP WHILE SALICYLIC ACID HELPS DIMINISH THEM DURING WEAR..

DIST. BY
COVER FX SKIN CARE INC.
TORONTO, ONTARIO
CANADA M3J 2W8
MADE IN USA
WWW.COVERFX.COM

OBEUS S.A. 1030 BRUSSELS

CoverFx BlemPrim1

CoverFX Blem Prim 014

CoverFx BlemPrim2

COVER FX BLEMISH TREATMENT PRIMER
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68327-014
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.1425 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
LAMINARIA ANGUSTATA (UNII: 2J2UIK8XBZ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARRAGEENAN (UNII: 5C69YCD2YJ)
CHLORPHENESIN (UNII: I670DAL4SZ)
LEMON OIL (UNII: I9GRO824LL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERETH-18 (UNII: SA5E43C17C)
GLYCERETH-18 ETHYLHEXANOATE (UNII: IWS58C6V2Y)
GLYCERIN (UNII: PDC6A3C0OX)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%) (UNII: M825OX60H9)
LACTIC ACID (UNII: 33X04XA5AT)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
TEA TREE OIL (UNII: VIF565UC2G)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
QUILLAJA SAPONARIA BARK (UNII: 8N0K3807ZW)
ROSEMARY (UNII: IJ67X351P9)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
THYME OIL (UNII: 2UK410MY6B)
THYMUS VULGARIS LEAF (UNII: GRX3499643)
GINGER (UNII: C5529G5JPQ)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68327-014-01	15 mL in 1 TUBE; Type 0: Not a Combination Product	07/01/2014	12/31/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	07/01/2014	12/31/2016

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

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

Name	Address	ID/FEI	Business Operations
Establishment
MANA Products, Inc		078870292	manufacture(68327-014)

Revised: 12/2017

Document Id: 608a25f5-ca00-807e-e053-2991aa0a1eda

Set id: f18ab94b-a567-471f-8885-f6480aac00d2

Version: 3

Effective Time: 20171217

Cover FX Skin Care, Inc.

Drug Facts Active ingredient