drug facts

drug facts
SPL v1
SPL
SPL Set ID 534cebb1-1c69-44b0-8407-e5863d7eaa31
Route
topical
Published
Effective Date 2017-03-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (20 mg)
Inactive Ingredients
water diethylene glycol monoethyl ether ethylhexyl palmitate cetyl alcohol methyl methacrylate/glycol dimethacrylate crosspolymer polyethylene glycol 400 laureth-4 dimethicone aloe vera leaf polysorbate 80 diethanolamine cetyl phosphate polyacrylamide (1500 mw) 1,2-propanediol, 1-benzoate sodium citrate, unspecified form levomenol c13-14 isoparaffin xanthan gum edetate disodium diazolidinyl urea methylparaben propylparaben

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2014-05-01

Purpose

Acne treatment

Description

Salicylic Acid 2%


Medication Information

Warnings

For external use only

Purpose

Acne treatment

Directions
  • Clean the skin thoroughly before applying this product.
  • Apply a thin layer to affected area once a day before bedtime.
  • If bothersome dryness or peeling occurs, reduce application to every other day.
  • Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated.
Inactive Ingredients

Water, Ethoxydiglycol, Ethylhexyl Palmitate, Cetyl Alcohol, Glycerin, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, PEG-8, Laureth-4, Dimethicone, Aloe Barbadensis Leaf Juice, Polysorbate 80, DEA-Cetyl Phosphate, Polyacrylamide, Propylene Glycol, Sodium Citrate, Bisabolol, C13-14 Isoparaffin, Xanthan Gum, Disodium EDTA, Diazolidinyl Urea, Methylparaben, Propylparaben

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

© 2014 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

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

CVS ® Quality

Money Back Guarantee

V-13649

PLEASE RECYCLE

V-31490

#987593

FP409

M050790

Description

Salicylic Acid 2%

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.

Active Ingredient

Salicylic Acid 2%

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, only use one topical acne medication at a time.
  • avoid contact with eyes. If contact occurs, flush thoroughly with water
Principal Display Panel Tube Label

SKIN+PHARMACY

ADVANCED

ACNE

THERAPY

OVERNIGHT

SALICYLIC ACID LOTION

with Microsponge
® Technology

Maximum Strength

2% Salicylic Acid

  • works overnight to help eliminate existing blemishes
  • helps prevent new breakouts from forming
  • contains anti-inflammatory Bisabolol & soothing Aloe Vera to calm skin
  • fragrance- & oil-free formula

DERMATOLOGIST TESTED

exclusively at

CVS/pharmacy

1 FL OZ (30 mL)

Principal Display Panel Carbon Label

SKIN+

PHARMACY

ADVANCED

ACNE

THERAPY

OVERNIGHT

SALICYLIC

ACID

LOTION

with Microsponge
®

Technology

Maximum Strength 2% Salicylic Acid

  • works overnight to help eliminate existing blemishes
  • helps prevent new breakouts from forming
  • contains anti-inflammatory Bisabolol & soothing Ale Vera to calm skin
  • fragrance- & oil-free formula

DERMATOLOGIST TESTED

exclusively at

CVS/pharmacy

Actual Size Product

on Side Panel

1 FL OZ (30 mL)


Structured Label Content

Warnings

For external use only

Purpose

Acne treatment

Directions
  • Clean the skin thoroughly before applying this product.
  • Apply a thin layer to affected area once a day before bedtime.
  • If bothersome dryness or peeling occurs, reduce application to every other day.
  • Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated.
Inactive Ingredients (Inactive ingredients)

Water, Ethoxydiglycol, Ethylhexyl Palmitate, Cetyl Alcohol, Glycerin, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, PEG-8, Laureth-4, Dimethicone, Aloe Barbadensis Leaf Juice, Polysorbate 80, DEA-Cetyl Phosphate, Polyacrylamide, Propylene Glycol, Sodium Citrate, Bisabolol, C13-14 Isoparaffin, Xanthan Gum, Disodium EDTA, Diazolidinyl Urea, Methylparaben, Propylparaben

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

© 2014 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

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

CVS ® Quality

Money Back Guarantee

V-13649

PLEASE RECYCLE

V-31490

#987593

FP409

M050790

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.

Active Ingredient

Salicylic Acid 2%

When Using This Product (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, only use one topical acne medication at a time.
  • avoid contact with eyes. If contact occurs, flush thoroughly with water
Principal Display Panel Tube Label (Principal Display Panel - Tube Label)

SKIN+PHARMACY

ADVANCED

ACNE

THERAPY

OVERNIGHT

SALICYLIC ACID LOTION

with Microsponge
® Technology

Maximum Strength

2% Salicylic Acid

  • works overnight to help eliminate existing blemishes
  • helps prevent new breakouts from forming
  • contains anti-inflammatory Bisabolol & soothing Aloe Vera to calm skin
  • fragrance- & oil-free formula

DERMATOLOGIST TESTED

exclusively at

CVS/pharmacy

1 FL OZ (30 mL)

Principal Display Panel Carbon Label (Principal Display Panel - Carbon Label)

SKIN+

PHARMACY

ADVANCED

ACNE

THERAPY

OVERNIGHT

SALICYLIC

ACID

LOTION

with Microsponge
®

Technology

Maximum Strength 2% Salicylic Acid

  • works overnight to help eliminate existing blemishes
  • helps prevent new breakouts from forming
  • contains anti-inflammatory Bisabolol & soothing Ale Vera to calm skin
  • fragrance- & oil-free formula

DERMATOLOGIST TESTED

exclusively at

CVS/pharmacy

Actual Size Product

on Side Panel

1 FL OZ (30 mL)


Advanced Ingredient Data


Raw Label Data

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