ANTI ACNE CALMING CORRECTOR- salicylic acid gel

Anti Acne Calming Corrector by

Drug Labeling and Warnings

Anti Acne Calming Corrector by is a Otc medication manufactured, distributed, or labeled by H2O Plus. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient
Salicylic Acid 1.5%

 Purpose
acne treatment

Warnings
For external use only.

Ask a doctor of pharmacist before use
if you are using other topical acne
medications at the same time or
immediately following use of this product.
This may increase dryness or irritation of
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, rinse
thoroughly with water.

Keep out of reach of children. If
swallowed, get medical help or contact
a Poison Control Center right away. If
excessive skin irritation develops or
increases, discontinue use and consult
a doctor.

Directions
Cleanse the skin thoroughly before
applying medication. Cover the entire
affected area with a thin layer one to three
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 (Aqua), SD Alcohol 40-B, Hamamelis
Virginiana (Witch Hazel) Bark/Leaf/Twig
Extract, Butylene Glycol, Glycerin, Glycolic
Acid, Sodium Lactate, Linoleamidopropyl
PG-Dimonium Chloride Phosphate,
Hydroxyethylcellulose, Sodium Hydroxide,
Fragrance (Parfum), Polysorbate 20,
Polyquaternium-10, Hydrolyzed Algin,
Linalool, Propylene Glycol, Sea Salt (Maris
Sal), Palmaria Palmata Extract, Crithmum
Maritimum Extract, Himanthalia Elongata
Extract, Gigartina Stellata Extract,
Macrocystis Pyrifera Extract, Zinc Sulfate

Questions? call 1-800-242-2284
M-F, 8am-6pm CST

PRINCIPAL DISPLAY PANEL

picture of carton label aacc272.jpg

INGREDIENTS AND APPEARANCE

ANTI ACNE CALMING CORRECTOR 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65903-272
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	15 uL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCOLIC ACID (UNII: 0WT12SX38S)
SODIUM LACTATE (UNII: TU7HW0W0QT)
LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SEA SALT (UNII: 87GE52P74G)
DULSE (UNII: 7832HOY4ZQ)
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)
HIMANTHALIA ELONGATA (UNII: 21RND18XRR)
MASTOCARPUS STELLATUS (UNII: 6T087FC66H)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
ZINC SULFATE (UNII: 89DS0H96TB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65903-272-02	1 in 1 CARTON
1	NDC: 65903-272-01	25 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	03/01/2010

Labeler - H2O Plus (807722947)

Registrant - H2O Plus (807722947)

Establishment
Name	Address	ID/FEI	Business Operations
H2O Plus		807722947	manufacture