Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 03bbb445-4c6b-4f54-bd95-9f5764eae4e4
Route
TOPICAL
Published
Effective Date 2017-03-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (5 mg)
Inactive Ingredients
Water Kaolin Glycerin Bentonite Butylene Glycol Cetostearyl Alcohol Methyl Methacrylate/glycol Dimethacrylate Crosspolymer Cocamidopropyl Betaine Peg-100 Stearate Magnesium Aluminum Silicate Glyceryl Monostearate Phenoxyethanol Polyoxyl 20 Cetostearyl Ether Xanthan Gum Chlorphenesin Caffeine Ethylhexylglycerin Edetate Disodium Citric Acid Monohydrate Sodium Hydroxide .alpha.-tocopherol Acetate Vitamin A Palmitate Ascorbyl Palmitate Levomenol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-07-01

Description

Salicylic Acid 0.5%

Purpose

Acne


Medication Information

Purpose

Acne

Description

Salicylic Acid 0.5%

Use

for the management of acne

Section 50565-1

Keep out of reach of children. Do not swallow. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only

Directions
  • Once to twice per week, apply a generous layer evenly onto cleansed skin avoiding the eye area.
  • Leave on for 10 minutes.
  • Rinse thoroughly with water.
  • Follow with your favorite Skin+Pharmacy moisturizer.
Active Ingredient

Salicylic Acid 0.5%

Inactive Ingredients

Water, Kaolin, Glycerin, Bentonite, Butylene Glycol, Cetearyl Alcohol, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Cocamidopropyl Betaine, PEG-100 Stearate, Magnesium Aluminum Silicate, Glyceryl Stearate, Phenoxyethanol, Ceteareth-20, Xanthan Gum, Chlorphenesin, Caffeine, Ethylhexylglycerin, Disodium EDTA, Citric Acid, Sodium Hydroxide, Tocopheryl Acetate, Retinyl Palmitate, Ascorbyl Palmitate, Bisabolol.

Microsponge® 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

© 2016 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

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

V-13649

CVS ® Quality

Money Back Guarantee

M050873CP

FP419

#742825

When Using This Product
  • using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
  • avoid contact with eye. if contact occurs, flush thoroughly with water.
  • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
Principal Display Panel Tube Label

SKIN+

PHARMACY

ADVANCED

ACNE

THERAPY

PORE REFINING

FACIAL MASK

with Microsponge
®

Technology

0.5% Salicylic Acid

  • contains anti-inflammatory Bisabolol & Vitamins A & E
  • helps eliminate & prevent blemishes
  • unclogs pores
  • fragrance & oil-free formula

DERMATOLOGIST TESTED

exclusively at

CVS/pharmacy

3.3 FL OZ (99 mL)

Principal Display Panel Carton Label

SKIN+

PHARMACY

ADVANCED

ACNE

THERAPY

PORE REFINING

FACIAL MASK

with Microsponge
®

Technology

0.5% Salicylic Acid

  • contains anti-inflammatory Bisabolol & Vitamins A & E
  • helps eliminate & prevent blemishes
  • unclogs pores
  • fragrance & oil-free formula

DERMATOLOGIST TESTED

exclusively at

CVS/pharmacy

Actual Product Size

on Side Panel

3.3 FL OZ (99 mL)


Structured Label Content

Use

for the management of acne

Section 50565-1 (50565-1)

Keep out of reach of children. Do not swallow. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Acne

Warnings

For external use only

Directions
  • Once to twice per week, apply a generous layer evenly onto cleansed skin avoiding the eye area.
  • Leave on for 10 minutes.
  • Rinse thoroughly with water.
  • Follow with your favorite Skin+Pharmacy moisturizer.
Active Ingredient

Salicylic Acid 0.5%

Inactive Ingredients (Inactive ingredients)

Water, Kaolin, Glycerin, Bentonite, Butylene Glycol, Cetearyl Alcohol, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Cocamidopropyl Betaine, PEG-100 Stearate, Magnesium Aluminum Silicate, Glyceryl Stearate, Phenoxyethanol, Ceteareth-20, Xanthan Gum, Chlorphenesin, Caffeine, Ethylhexylglycerin, Disodium EDTA, Citric Acid, Sodium Hydroxide, Tocopheryl Acetate, Retinyl Palmitate, Ascorbyl Palmitate, Bisabolol.

Microsponge® 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

© 2016 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

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

V-13649

CVS ® Quality

Money Back Guarantee

M050873CP

FP419

#742825

When Using This Product (When using this product)
  • using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
  • avoid contact with eye. if contact occurs, flush thoroughly with water.
  • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
Principal Display Panel Tube Label (Principal Display Panel - Tube Label)

SKIN+

PHARMACY

ADVANCED

ACNE

THERAPY

PORE REFINING

FACIAL MASK

with Microsponge
®

Technology

0.5% Salicylic Acid

  • contains anti-inflammatory Bisabolol & Vitamins A & E
  • helps eliminate & prevent blemishes
  • unclogs pores
  • fragrance & oil-free formula

DERMATOLOGIST TESTED

exclusively at

CVS/pharmacy

3.3 FL OZ (99 mL)

Principal Display Panel Carton Label (Principal Display Panel - Carton Label)

SKIN+

PHARMACY

ADVANCED

ACNE

THERAPY

PORE REFINING

FACIAL MASK

with Microsponge
®

Technology

0.5% Salicylic Acid

  • contains anti-inflammatory Bisabolol & Vitamins A & E
  • helps eliminate & prevent blemishes
  • unclogs pores
  • fragrance & oil-free formula

DERMATOLOGIST TESTED

exclusively at

CVS/pharmacy

Actual Product Size

on Side Panel

3.3 FL OZ (99 mL)


Advanced Ingredient Data


Raw Label Data

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