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Acni Spot

Dosage form: liquid
Ingredients: Salicylic Acid 1.93mL in 96.5mL
Labeler: La Jolla
NDC Code: 35658-000

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 Fcts

Salicylic Acid 2% Acne Treatment

When using this product avoid contact with eyes. If contact occurs, immediately flush with water.

Warnings: Forexternal use only.
Do not use if using other topical acne medications at the same time or immediately
following use of this product as it may increase dryness or irritation of the skin. If
this occurs, only one medication should be used unless directed by a physician.

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

Cleanse the skin thoroughly before applying medication. Cover the entire affected area
with a thin layer one to three times dally. 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.

Other lngredients: Water, SD AlcohoI40-B. Glycolic Acid, Urea, Propylene
Glycol, Ammonium Glycolate, Allantoin, Bisabolol, Nonoxynol-9. Disodium EDTA

acni spot liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35658-000
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (Salicylic Acid) Salicylic Acid1.93 mL  in 96.5 mL
#Item CodePackage Description
1NDC:35658-000-0325 BOTTLE (BOTTLE) in 1 CASE
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D07/01/2009
Labeler - La Jolla (021918650)
Registrant - Harmony Labs, Inc. (105803274)
Harmony Labs, Inc.105803274manufacture, label, pack, relabel, repack

Revised: 05/2010
La Jolla

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.