SALICYLIC ACID by CVS / Pharma Pac, LLC SALICYLIC ACID liquid

SALICYLIC ACID by

Drug Labeling and Warnings

SALICYLIC ACID by is a Otc medication manufactured, distributed, or labeled by CVS, Pharma Pac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Active ingredient                 Purpose
Salicylic Acid
(0.5%)..............................Acne Medication
______________________________________

Use for the management of acne

KEEP OUT OF REACH OF CHILDREN

_______________________________

Keep out of reach of children. In
case of accidental ingestion, get
medical help or contact a Poison
Control Center right away.

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.

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

INGREDIENTS AND APPEARANCE

SALICYLIC ACID 
salicylic acid liquid

Product 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