SALICYLIC ACID: Package Insert and Label Information

SALICYLIC ACID — salicylic acid liquid
CVS

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.

Active ingredient Purpose
Salicylic Acid
(0.5%)………………………………Acne Medication

Active ingredient Purpose
Salicylic Acid
(0.5%)…………………………Acne Medication
______________________________________
Use for the management of acne
_______________________________
Keep out of reach of children. In
case of accidental ingestion, get
medical help or contact a Poison
Control Center right away.
Use for the management of acne
_______________________________
Directions
– Cleanse skin thoroughly before
applying medication
– cover the entire affected area with
a thin layer one to two times daily
– because excessive drying of the
skin may occur, start with one
application daily, then gradually
increase to two or three times
daily if needed or as directed by
a doctor
– if bothersome dryness or peeling
occurs, reduce application to
once a day or every other day Warnings
For external use only.

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.
______________________________
When using this product avoid
contact with eyes. If contact occurs,
immediately flush with water.
_______________________________
Keep out of reach of children. In
case of accidental ingestion, get
medical help or contact a Poison
Control Center right away.

Directions
– Cleanse skin thoroughly before
applying medication
– cover the entire affected area with
a thin layer one to two times daily
– because excessive drying of the
skin may occur, start with one
application daily, then gradually
increase to two or three times
daily if needed or as directed by
a doctor
– if bothersome dryness or peeling
occurs, reduce application to
once a day or every other day
Inactive Ingredients Water,
Dicaprylyl Ether, Glycerin,
Dimethicone, Neopentyl Glycol
Diethylhexanonate, Neopentyl Glycol
Diisostearate, Aluminum Starch,
Octenylsuccinate, Methyl Gluceth
-20, Diacetyl Phosphate, Ceteth-10
Phosphate, Cetearyl Alcohol,
Menthyl Lactate, Steareth-20,
Steareth-2, Fragrance, Xanthan
Gum, Lecithin, Disodium EDTA,
Sodium Hydroxide, MagnesiumAluminum Silicate, BHT
label
(click image for full-size original)
SALICYLIC ACID salicylic acid liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-078
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water
DICAPRYLYL ETHER
DIMETHICONE
SODIUM LAURYL SULFATE
ALUMINUM STARCH OCTENYLSUCCINATE
CETOSTEARYL ALCOHOL
METHYL GLUCETH-20
METHYLCHLOROISOTHIAZOLINONE
MENTHYL LACTATE
STEARETH-20
XANTHAN GUM
LECITHIN, SOYBEAN
EDETATE DISODIUM
SODIUM HYDROXIDE
MAGNESIUM ALUMINUM SILICATE
BUTYLATED HYDROXYTOLUENE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-078-08 120 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 05/19/2009
Labeler — CVS (062312574)
Registrant — Pharma Pac, LLC (140807475)
Establishment
Name Address ID/FEI Operations
Pharma Pac, LLC 140807475 manufacture

Revised: 02/2011 CVS

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