Label: SALIC-2- salicylic acid gel

  • 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.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Salicylic Acid (2%)

  • Purpose

    Acne Medication

  • Uses For acne treatment

    • Reduces the number of whiteheads, blackheads and acne blemishes.
  • Warnings

    For external use only

    When using this product

    • Avoid contact with the eyes. If contact occurs, rinse thoroughly with water.
    • Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only one medication should be used unless directed by a doctor.

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

  • 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

    • Keep tightly closed
    • Store in a cool & dry place.
  • Inactive ingredients

    Water, Propylene Glycol, Disodium Hydrogen Phosphate Anhydrous, Sodium Lauryl Sulphate, Chlorocresol, Carbopol 940, Fragrance SSC-929/BRH

  • Questions ?

    1(856) 2863646

  • SPL UNCLASSIFIED SECTION

    Distributed by :
    Sohm, Inc.
    6920 Knott Ave., Suite A-C
    Buena Park, CA 90621

    Manufactured by
    Sohm (India) Pvt. Ltd. India.

  • PRINCIPAL DISPLAY PANEL - 60g Tube Label

    Salicylic Acid 2% Gel

    Acne Treatment
    A Complete Fresh Face Wash Gel

    Salic-2®

    Acne Control

    Exfoliating

    Age Defying

    Rejuvenating

    2.12 OZ 60g)

    PRINCIPAL DISPLAY PANEL - 60g Tube Label
  • INGREDIENTS AND APPEARANCE
    SALIC-2 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50405-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid1.2 g  in 60 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50405-110-0160 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D11/15/2013
    Labeler - SOHM Inc. (009303848)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!