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Anti Acne Calming Corrector

Dosage form: gel
Ingredients: Salicylic Acid 15uL in 1mL
Labeler: H2O Plus
NDC Code: 65903-272

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 Facts

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

picture of carton label aacc272.jpg

ANTI ACNE CALMING CORRECTOR 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65903-272
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (Salicylic Acid) Salicylic Acid15 uL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
ALCOHOL 
HAMAMELIS VIRGINIANA BARK 
BUTYLENE GLYCOL 
GLYCERIN 
GLYCOLIC ACID 
SODIUM LACTATE 
LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE 
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) 
SODIUM HYDROXIDE 
POLYSORBATE 20 
POLYQUATERNIUM-10 (400 CPS AT 2%) 
LINALOOL, (+/-)- 
PROPYLENE GLYCOL 
SEA SALT 
DULSE 
CRITHMUM MARITIMUM 
HIMANTHALIA ELONGATA 
MASTOCARPUS STELLATUS 
MACROCYSTIS PYRIFERA 
ZINC SULFATE 
Packaging
#Item CodePackage Description
1NDC:65903-272-021 BOTTLE, PUMP (BOTTLE) in 1 CARTON
1NDC:65903-272-0125 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D03/01/2010
Labeler - H2O Plus (807722947)
Registrant - H2O Plus (807722947)
Establishment
NameAddressID/FEIOperations
H2O Plus807722947manufacture

Revised: 09/2011
 
H2O Plus

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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