Label: ACNI SPOT liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 35658-000-03 - Packager: La Jolla
- Category: HUMAN OTC DRUG LABEL
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 May 24, 2010
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- WHEN USING
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACNI SPOT
acni spot liquidProduct 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