Label: SALICYLIC ACID liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 59779-078-08 - Packager: CVS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 16, 2011
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
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
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.
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DOSAGE & ADMINISTRATION
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 INGREDIENT
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 - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SALICYLIC ACID
salicylic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-078 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-078-08 120 mL in 1 BOTTLE 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 Business Operations Pharma Pac, LLC 140807475 manufacture
