SPL v1
SPL
SPL Set ID a2401d2e-291c-4ce4-bdde-d45b11afc9a7
Route
TOPICAL
Published
Effective Date 2016-10-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 g) Benzoyl Peroxide (25 g)
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 Glycerin Methyl Methacrylate/glycol Dimethacrylate Crosspolymer Cetyl Alcohol Sorbitol Glyceryl Dilaurate Stearyl Alcohol Magnesium Aluminum Silicate Sodium Citrate Silicon Dioxide Sodium Lauryl Sulfate Citric Acid Monohydrate Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-10-01

Description

Drug Facts

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Drug Facts

Use
  • for the management of acne
Section 42229-5

Drug Facts

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.

M050775

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 a 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
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.

Principal Display Panel Skin+pharmacy Advanced Acne Therapy Kit 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

4 FL OZ (118 mL)

Principal Display Panel Skin+pharmacy Advanced Acne Therapy Kit Carton Label

SKIN+PHARMACY

ADVANCED

ACNE THERAPY KIT

DERMATOLOGIST TESTED

BONUS:

Includes 2 Gentle Facial

Cleansing Sponges

exclusively at

CVS/pharmacy

$35 VALUE

$19.99

ONE MONTH SUPPLY


Structured Label Content

Use
  • for the management of acne
Section 42229-5 (42229-5)

Drug Facts

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 Treatment

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.

M050775

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 a 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
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.

Principal Display Panel Skin+pharmacy Advanced Acne Therapy Kit Label (Principal Display Panel - Skin+Pharmacy Advanced Acne Therapy Kit 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

4 FL OZ (118 mL)

Principal Display Panel Skin+pharmacy Advanced Acne Therapy Kit Carton Label (Principal Display Panel - Skin+Pharmacy Advanced Acne Therapy Kit Carton Label)

SKIN+PHARMACY

ADVANCED

ACNE THERAPY KIT

DERMATOLOGIST TESTED

BONUS:

Includes 2 Gentle Facial

Cleansing Sponges

exclusively at

CVS/pharmacy

$35 VALUE

$19.99

ONE MONTH SUPPLY


Advanced Ingredient Data


Raw Label Data

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