KERALYT 3 PERCENT (SALICYLIC ACID) GEL [SUMMERS LABORATORIES INC]

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KERALYT 3 PERCENT (SALICYLIC ACID) GEL [SUMMERS LABORATORIES INC]
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NDC 11086-038-01
Set ID c02018de-3b03-49b7-9152-c65b248345ad
Category HUMAN OTC DRUG LABEL
Packager Summers Laboratories Inc
Generic Name
Product Class
Product Number
Application Number PART358H
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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    SALICYLIC ACID 3%

  • PURPOSE

    PURPOSE

    PSORIASIS, SEBORRHEIC DERMATITIS

  • INDICATIONS & USAGE

    USES

    HELPS STOP THESE SYMPTOMS OF PSORIASIS, SEBORRHEIC DERMATITIS AND DANDRUFF

    • FLAKING
    • SCALING
    • REDNESS
    • IRRITATION
    • ITCHING
  • WARNINGS

    WARNINGS

    FOR EXTERNAL USE ONLY

  • ASK DOCTOR

    ASK A DOCTOR BEFORE USE IF CONDITION COVERS A LARGE AREA OF THE BODY

    WHEN USING THIS PRODUCT

    • DO NOT GET INTO EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER. IF IRRITATION PERSISTS, CONSULT A DOCTOR.

    STOP USE AND CONSULT A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE.

    KEEP OUT OF REACH OF CHILDREN. IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

    FLAMMABLE

  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • APPLY TO AFFECTED AREA ONE TO FOUR TIMES DAILY OR AS DIRECTED BY A DOCTOR.
  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

    PROPYLENE GLYCOL, SD-40 ALCOHOL (21%), WATER, HYDROXYPROPYLCELLULOSE

  • PRINCIPAL DISPLAY PANEL

    Keralyt 3-SA_Unit Carton

  • INGREDIENTS AND APPEARANCE
    KERALYT   3 PERCENT
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11086-038
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11086-038-0128.4 g in 1 TUBE; Type 0: Not a Combination Product10/30/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H10/30/2013
    Labeler - Summers Laboratories Inc (002382612)
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