Label: GLY-SAL 10-2 PADS- salicylic acid cloth

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 23, 2019

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic Acid USP, 2%

  • Purpose

    Acne medication

  • Uses

    Cleansing pads for the treatment of acne, with the skin enhancement properties of Glycolic acid.

  • Warnings

    • For external use only.
    • Keep away from eyes, lips, and mouth.

    • If irritation develops, discontinue use and consult a doctor.

    • Using other topical acne medication at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

    • Keep out of reach of children. If swallowed, seek professional assistance or contact a Poison Control Center immediately.

    • Flammable; keep tightly closed, away from flame and heat.
    • Sunscreen use is recommended with any Glycolic Acid product and for an additional week thereafter, because some individuals may be more sensitive to sunlight.
  • Directions

    • Wipe the entire affected area with a moist pad one to three times daily.
    • Because excessive drying of the skin can occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a physician.
    • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • Inactive ingredients

    Purified Water, Glycolic Acid, SD Alcohol 40B(13% v/v), Hamamelis Virginiana (Witch Hazel) Water, Ammonium Hydroxide, Polysorbate-20, Sodium Benzoate, Imidazolidinyl Urea, Acetone, Disodium EDTA.

  • PRINCIPAL DISPLAY PANEL - 60 Pad Jar Label

    REPLENiX®
    ACNE SOLUTIONS

    Topix Pharmaceuticals, Inc.
    N. Amityville, NY 11701

    Gly/Sal® 10-2
    Pads

    Glycolic Acid 10%
    Salicylic Acid USP, 2%

    60 Pads

    PRINCIPAL DISPLAY PANEL - 60 Pad Jar Label
  • INGREDIENTS AND APPEARANCE
    GLY-SAL 10-2 PADS 
    salicylic acid cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51326-039
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.02 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    ALCOHOL (UNII: 3K9958V90M)  
    HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
    AMMONIA (UNII: 5138Q19F1X)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    IMIDUREA (UNII: M629807ATL)  
    ACETONE (UNII: 1364PS73AF)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51326-039-6060 in 1 JAR; Type 0: Not a Combination Product07/28/2000
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM00607/28/2000
    Labeler - Topiderm, Inc. (049121643)
    Registrant - Topiderm, Inc. (049121643)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topiderm, Inc.049121643MANUFACTURE(51326-039)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topix Pharmaceuticals, Inc.117745066PACK(51326-039)
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!