Label: SALIC-2- salicylic acid gel
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Contains inactivated NDC Code(s)
NDC Code(s): 50405-110-01 - Packager: SOHM Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 November 11, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses For acne treatment
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Warnings
For external use only
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Directions
- Clean the skin thoroughly before applying product.
- Cover the entire affected area with a thin layer one to three times daily.
- Relax for 2-3 minutes, then rinse.
- Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed or directed by a doctor.
- If both dryness and peeling occurs, reduce application to once a day or every other day.
- Other information
- Inactive ingredients
- Questions ?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 60g Tube Label
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INGREDIENTS AND APPEARANCE
SALIC-2
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50405-110 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid 1.2 g in 60 g Inactive Ingredients Ingredient Name Strength Propylene Glycol (UNII: 6DC9Q167V3) Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F) Sodium Lauryl Sulfate (UNII: 368GB5141J) Chlorocresol (UNII: 36W53O7109) Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50405-110-01 60 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333D 11/15/2013 Labeler - SOHM Inc. (009303848)