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Name:Acni Spot
Manufacturer:La Jolla
Category:Over-the-counter (OTC) Marketed Drugs

Drug Fcts

ACNI SPOT  - salicylic acid liquid 
La Jolla

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

Label Front
Label Back

acni spot liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:35658-000
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Salicylic Acid (Salicylic Acid) Salicylic Acid 1.93 mL  in 96.5 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
# Item Code Package Description Multilevel Packaging
1 NDC:35658-000-03 25 BOTTLE ( BOTTLE) in 1 CASE contains a BOTTLE
1 15 mL in 1 BOTTLE This package is contained within the CASE (35658-000-03)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 07/01/2009

Labeler - La Jolla (021918650)
Registrant - Harmony Labs, Inc. (105803274)
Name Address ID/FEI Operations
Harmony Labs, Inc. 105803274 manufacture, label, pack, relabel, repack

Revised: 05/2010 La Jolla

Reproduced with permission of U.S. National Library of Medicine

Copyright © 2018 by Dionisios Fentas || Terms of Use


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