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Pedi-Boro Soak Paks (Pedinol Pharmacal, Inc.)

Available Formats

Dosage Form Package Information Links
POWDER, FOR SOLUTION 100 POWDER, FOR SOLUTION in 1 BOX (0884-1706-10) Label Information
POWDER, FOR SOLUTION 12 POWDER, FOR SOLUTION in 1 BOX (0884-1706-27) Label Information

Complete Pedi-Boro Soak Paks Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    Active Ingredient (in each packet) Purpose

    Aluminum sulfate tetradecahydrate, 1191 mg

    Astringent*

    Calcium acetate monohydrate, 839 mg

    Astringent*

    *When combined together in water, these ingredients form the active ingredient aluminum acetate. See Directions.


  • Uses

    Temporarily relieves minor skin irritations due to:

    • poison ivy
    • poison oak
    • poison sumac
    • insect bites
    • athlete's foot
    • rashes caused by soaps, detergents, cosmetics or jewelry

  • Warnings

    For external use only

    When using this product

    • avoid contact with eyes. If contact occurs, rinse thoroughly with water.
    • do not cover compress or wet dressing with plastic to prevent evaporation
    • in some skin conditions, soaking too long may overdry

    Stop use and ask a doctor if

    • condition worsens or symptoms last more than 7 days

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.


  • Directions

    • dissolve 1 to 3 packets in a pint (16 oz) of cool or warm water
    • stir until fully dissolved; do not strain or filter. The resulting mixture contains 0.13% (1 packet), 0.26% (2 packets), or 0.41% (3 packets) aluminum acetate and is ready for use.

    For use as a soak:

    • soak affected area for 15 to 30 minutes as needed, or as directed by a doctor
    • repeat 3 times a day or as directed by a doctor
    • discard solution after each use

    For use as a compress or wet dressing:

    • soak a clean, soft cloth in the solution
    • apply cloth loosely to affected area for 15 to 30 minutes
    • repeat as needed or as directed by a doctor
    • discard solution after each use

  • Inactive ingredient

    mint green shade (FD&C Yellow No. 5 and FD&C Blue No. 1)


  • Questions or comments?

    Please call 1-800-321-4576 or visit us at www.pedinaol.com

    Retain this packaging for full directions and warnings.


  • SPL UNCLASSIFIED SECTION

    Distributed by:
    PEDiNOL, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 www.pedinol.com
    Rev. 10/14

    9428500


  • PRINCIPAL DISPLAY PANEL - 2.1 g packet

    PEDiNOL®
    pedi-boro®
    soak pak

    forms aluminum
    acetate astringent solution

    net wt. 2.1g

    Pedinol Pedi Boro Soak Pak Label

  • INGREDIENTS AND APPEARANCE
    PEDI-BORO SOAK PAKS 
    aluminum sulfate tetradecahydrate, calcium acetate monohydrate powder, for solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0884-1706
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALUMINUM ACETATE (UNII: 80EHD8I43D) (ALUMINUM CATION - UNII:3XHB1D032B) ALUMINUM ACETATE 615 mg
    Inactive Ingredients
    Ingredient Name Strength
    ALUMINUM SULFATE TETRADECAHYDRATE (UNII: E3UT66504P) 1191 mg
    CALCIUM ACETATE MONOHYDRATE (UNII: 7ZA48GIM5H) 839 mg
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Color GREEN (mint green) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0884-1706-27 12 in 1 BOX
    2 NDC:0884-1706-10 100 in 1 BOX
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 01/15/2013
    Labeler - Pedinol Pharmacal, Inc. (064737125)
    Registrant - Valeant Pharmaceuticals North America LLC (042230623)
    Establishment
    Name Address ID/FEI Business Operations
    ULTRAtab Laboratories, Inc. 151051757 MANUFACTURE(0884-1706)