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.

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drug facts

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, Magnesium
Aluminum Silicate, BHT

label


SALICYLIC ACID 
salicylic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-078
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
MENTHYL LACTATE (UNII: 2BF9E65L7I)  
STEARETH-20 (UNII: L0Q8IK9E08)  
XANTHAN GUM (UNII: TTV12P4NEE)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-078-08120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D05/19/2009
Labeler - CVS (062312574)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 2/2011
Document Id: 133e11e4-2ec4-4e9c-9d95-ac8d386d90d2
Set id: d45a117b-e274-4cbb-9915-a177a817dc55
Version: 5
Effective Time: 20110216
 
CVS