Label: ALA-SEPTIC- salicyclic acid cream

  • 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 December 16, 2013

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  • warnings

    For external use only.

    Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    Do not use without consulting a doctor if the condition appears over a large portion of hte body.

    If condition worsens, or does not improve after using as directed, consult physician.

    Do not use for prolonged periods without consulting a docotor.

  • Active ingredient

    Salicylic Acid 2.00%

  • Purpose

    Dermatitis Treatment

  • Use for:

    For relief of itching, irritation, redness and scaling assoicated with psoriasis, eczema and seborrheic dermatitis.

  • Other ingredients:

    Aloe Barbadensis Leaf Juice, Aqua (deionized water), benzoic acid, butylene glycol, C13-14 isoparaffin, ethylhexylglycerin, glycrrhiza glabra (licorice) extract, iodoquinol, isoproply myristate, larrea tridentata extract, larueth-7, melaleuca alternifolia (tea tree) oil, phenoxyethanol, polyacrylamide, polysorbate-20, SD-alcohocl 40B, tocopheryl acetate (vitamin E).

  • Keep out of reach of children.

    If swallowed, contact physician or poison control center immediately.

  • Directions:

    Wash affected areas well with soap and water. Pat dry. Apply cream to affected area one to four times per day, or as directed by physician.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ALA-SEPTIC 
    salicyclic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59434-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    water (UNII: 059QF0KO0R)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    LICORICE (UNII: 61ZBX54883)  
    IODOQUINOL (UNII: 63W7IE88K8)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LARREA TRIDENTATA WHOLE (UNII: B755J144H1)  
    LAURETH-7 (UNII: Z95S6G8201)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALCOHOL (UNII: 3K9958V90M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59434-001-04100 g in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H10/01/2013
    Labeler - Ala-Septic Pharmaceutical Research LLC (964652692)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source969241041manufacture(59434-001)
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