Acni Spot by La Jolla / Harmony Labs, Inc. ACNI SPOT liquid

Acni Spot by

Drug Labeling and Warnings

Acni Spot by is a Otc medication manufactured, distributed, or labeled by La Jolla, Harmony Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Salicylic Acid 2% Acne Treatment

WHEN USING

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

WARNINGS

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

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

SPL UNCLASSIFIED SECTION

Directions:
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.

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

pictures

INGREDIENTS AND APPEARANCE

ACNI SPOT 
acni spot liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35658-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	1.93 mL  in 96.5 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35658-000-03	25 in 1 CASE
1		15 mL in 1 BOTTLE

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)

Establishment
Name	Address	ID/FEI	Business Operations
Harmony Labs, Inc.		105803274	manufacture, label, pack, relabel, repack