Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 682e43d2-3d85-4ac6-a38c-f39c0f078573
Route
TOPICAL
Published
Effective Date 2017-02-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Water Sodium C14-16 Olefin Sulfonate Polyethylene Glycol 4000 Cocamidopropyl Betaine Xanthan Gum Dmdm Hydantoin Edetate Disodium .alpha.-tocopherol Acetate, Dl- Hamamelis Virginiana Flower Water Butylene Glycol Calendula Officinalis Flower Licorice Phenoxyethanol Fd&c Yellow No. 5 Fd&c Red No. 40 Lauryl Methacrylate/glycol Dimethacrylate Crosspolymer

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-07-01

Description

2% Salicylic Acid

Purpose

Acne


Medication Information

Indications and Usage

Uses for the management of acne

Purpose

Acne

Description

2% Salicylic Acid

Section 50565-1

Keep out of reach of children. In case of accidental ingestion, get medical help or contact Poison Control Center right away.

Warnings

For external use only

Directions
  • Use morning and night.
  • Apply a dime sized amount to damp skin and gently massage for 1 to 2 minutes.
  • Rinse thoroughly with warm water. Pat dry.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • If going outside use sunscreen.
Active Ingredient

2% Salicylic Acid

Inactive Ingredients

Water, Sodium C14-16 Olefin Sulfonate, PEG-8, Cocamidopropyl Betaine, Xanthan Gum, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, DMDM Hydantoin, Disodium EDTA, Tocopheryl Acetate, Hamamelis Virginiana (Witch Hazel) Water, Butylene Glycol, Sodium Benzotriazolyl Butylphenol Sulfonate, Calendula Officinalis Flower Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Phenoxyethanol, Yellow 5, Red 40, Fragrance.

Polytrap® is a registered trademark of AMCOL International Corp.

Save carton for complete labeling since all warnings are not included on the inner package.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2014 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

Made in the U.S.A. of U.S. and imported components

V-31490

M050731

CVS® Quality

Money Back Guarantee

#971009

FP406

When Using This Product
  • Skin irritation and dryness are 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 the same time.
  • When using this product avoid contact with eyes. If this occurs, immediately flush with water.
Do Not Use This Medication If You
  • Have very sensitive skin
  • Are sensitive to salicylic acid
Principal Display Panel Bottle Label

SKIN+PHARMACY

ADVANCED

ACNE

THERAPY

CLARIFYING

DAILY CLEANSER

with Polytrap® Technology

Maximum Strength

2% Salicylic Acid

  • removes excess skin oils
  • unclogs pores
  • oil-free formula

DERMATOLOGIST TESTED

exclusively at CVS/pharmacy

5 FL OZ (148 mL)

Ask A Doctor Or Pharmacist Before Use If You Are

Using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.


Structured Label Content

Indications and Usage (34067-9)

Uses for the management of acne

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental ingestion, get medical help or contact Poison Control Center right away.

Purpose

Acne

Warnings

For external use only

Directions
  • Use morning and night.
  • Apply a dime sized amount to damp skin and gently massage for 1 to 2 minutes.
  • Rinse thoroughly with warm water. Pat dry.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • If going outside use sunscreen.
Active Ingredient

2% Salicylic Acid

Inactive Ingredients (Inactive ingredients)

Water, Sodium C14-16 Olefin Sulfonate, PEG-8, Cocamidopropyl Betaine, Xanthan Gum, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, DMDM Hydantoin, Disodium EDTA, Tocopheryl Acetate, Hamamelis Virginiana (Witch Hazel) Water, Butylene Glycol, Sodium Benzotriazolyl Butylphenol Sulfonate, Calendula Officinalis Flower Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Phenoxyethanol, Yellow 5, Red 40, Fragrance.

Polytrap® is a registered trademark of AMCOL International Corp.

Save carton for complete labeling since all warnings are not included on the inner package.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2014 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

Made in the U.S.A. of U.S. and imported components

V-31490

M050731

CVS® Quality

Money Back Guarantee

#971009

FP406

When Using This Product (When using this product)
  • Skin irritation and dryness are 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 the same time.
  • When using this product avoid contact with eyes. If this occurs, immediately flush with water.
Do Not Use This Medication If You (Do not use this medication if you)
  • Have very sensitive skin
  • Are sensitive to salicylic acid
Principal Display Panel Bottle Label (Principal Display Panel - Bottle Label)

SKIN+PHARMACY

ADVANCED

ACNE

THERAPY

CLARIFYING

DAILY CLEANSER

with Polytrap® Technology

Maximum Strength

2% Salicylic Acid

  • removes excess skin oils
  • unclogs pores
  • oil-free formula

DERMATOLOGIST TESTED

exclusively at CVS/pharmacy

5 FL OZ (148 mL)

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

Using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.


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