Label: SCRUB CARE POVIDONE IODINE CLEANSING SCRUB- povidone-iodine solution

  • NDC Code(s): 50425-010-59, 50425-010-94, 50425-010-95, 50425-010-96, view more
    50425-010-97, 50425-010-98
  • Packager: CareFusion 213 LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 08/12

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

  • Active ingredient

    Povidone-Iodine, USP 7.5% (0.75% available iodine)

    Close
  • Purpose

    Antiseptic

    Close
  • Uses

    For surgical hand scrub
    For preparation of skin and mucous membranes prior to surgery
    For hand washing to reduce bacteria on skin
    Close
  • Warnings

    For external use only
    Avoid use on persons allergic to iodine
    Do not use in the eyes
    Discontinue use if irritation and redness develop. If condition persist for more than 72 hours consult a doctor.

    Stop use and ask a doctor if

    Skin shows symptoms of irritation, sensitivity, redness, pain or swelling
    In case of deep puncture wounds or serious burns

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

    Close
  • Directions

    Surgical hand scrub: Wet hands and forearms with water; scrub for 3 minutes with about 5 ml of scrub and a wet brush; pay close attention to the nails, cuticles, and interdigital spaces; rinse thoroughly with running water; repeat
    Patient preoperative prep: Use full strength; apply solution saturated sponge to operative site; scrub in a circular motion for 5 minutes starting at incision site and move outward; blot with sterile towel; follow with application of topical solution
    For handwashing: Apply ample amount of solution to wet hands; wash in vigorous manner for 15 seconds; rinse and dry hands
    Close
  • Other information

    Store at room temperature
    Avoid excessive heat (above 104°F/40°C)
    Protect from freezing
    Latex Free
    Close
  • Inactive ingredients

    Alkyl Polyglucoside, Citric Acid, Nonylphenol Ethoxylate, Purified water, Sodium Hydroxide

    Close
  • Questions?

    Report serious side effects, call: 1-800-523-0502 Mon.-Fri. 8 AM-5 PM CST

    Close
  • Package/Label Principal Display Panel

    PVPI Scrub Principal Label

    Scrub Care PVP-I Scrub 4 oz Label

    Close
  • INGREDIENTS AND APPEARANCE
    SCRUB CARE POVIDONE IODINE CLEANSING SCRUB 
    povidone iodine solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50425-010
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (IODINE) IODINE 7.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE  
    WATER  
    SODIUM HYDROXIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50425-010-59 59 mL in 1 BOTTLE
    2 NDC:50425-010-98 118 mL in 1 BOTTLE
    3 NDC:50425-010-97 236 mL in 1 BOTTLE
    4 NDC:50425-010-96 472 mL in 1 BOTTLE
    5 NDC:50425-010-95 944 mL in 1 BOTTLE
    6 NDC:50425-010-94 3785 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 01/01/2001
    Labeler - CareFusion 213 LLC (831684456)
    Registrant - CareFusion 213 LLC (831684456)
    Establishment
    Name Address ID/FEI Business Operations
    Productos Urologos de Mexico, S.A. de C.V. 812552219 LABEL(50425-010), PACK(50425-010)
    Close