Label: ANTI ACNE CALMING CORRECTOR- salicylic acid gel
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Contains inactivated NDC Code(s)
NDC Code(s): 65903-272-01, 65903-272-02 - Packager: H2O Plus
- 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 September 28, 2011
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active Ingredient
Salicylic Acid 1.5%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.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 - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTI ACNE CALMING CORRECTOR
salicylic acid gelProduct 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