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

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 October 12, 2016

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

  • Active ingredient

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

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  • Purpose

    Antiseptic

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  • Uses

    • Surgical Hand Scrub: Significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care.
    • Patient Preoperative Skin Preparation: for preparation of skin prior to surgery.Helps reduce bacteria that potentially can cause skin infection.
    • Antiseptic Handwash: for hand washing to reduce bacteria on skin
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  • Warnings

    For external use only

    Do not use

    • in the eyes
    • on persons allergic to iodine

    Stop use and ask a doctor if

    • skin shows symptoms of irritation, sensitivity, redness, pain or swelling. If condition persists for more than 72 hours consult a doctor.
    • 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.

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  • Directions

    • Surgical hand scrub: clean under nails with a nail pick. Nails should be maintained with a 1 millimeter free edge; wet hands and forearms; scrub for 3 minutes with about 5 ml of scrub and a wet brush; pay particular attention to the nails, cuticles, and interdigital spaces; rinse and repeat
    • Patient Preoperative Prep: clean the area; apply solution saturated sponge; starting at the surgical site moving outward in concentric circles for a minimum of 5 minutes; blot with sterile towel; follow with application of topical solution
    • Antiseptic Handwash: wet hands and forearms; apply ample amount of solution to wet hands: wash in vigorous manner for 15 seconds; rinse and repeat
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  • Other information

    • store at room temperature
    • avoid excessive heat (above 104°F/40°C)
    • protect from freezing
    • latex free
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  • Inactive ingredients

    alkyl polyglucoside, citric acid, nonylphenol ethoxylate, purified water, sodium hydroxide

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  • Questions?

    Call: 1-800-523-0502 Mon.-Fri. 8 AM-5 PM CST

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  • Package/Label Principal Display Panel

    Cat. 29904-004

    NDA 50425-010-98

    Cat. 29904-004

    Scrub Care® 7.5%

    Povidone-iodine, Scrub

    Antiseptic

    Non-sterile Solution

    7.5% Povidone-iodine, USP

    For preparation of skin prior to surgery.

    Helps reduce bacteria that potentially can cause skin infection.

    For Single Use Only

    Manufactured for

    CareFusion

    Vernon Hills, IL 60061 USA

    51-10108

    Net Contents: 4 fl. oz. (118 ml)

    CareFusion

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  • INGREDIENTS AND APPEARANCE
    SCRUB CARE POVIDONE IODINE CLEANSING SCRUB 
    povidone iodine solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50425-010
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 7.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50425-010-59 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/19/2015
    2 NDC:50425-010-98 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/19/2015
    3 NDC:50425-010-97 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/19/2015
    4 NDC:50425-010-96 472 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/19/2015
    5 NDC:50425-010-95 944 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/19/2015
    6 NDC:50425-010-94 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/19/2015
    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 2200 Inc (832696038)
    Establishment
    Name Address ID/FEI Business Operations
    Thatcher Company 041307356 manufacture(50425-010)
    Establishment
    Name Address ID/FEI Business Operations
    CareFusion 213 LLC 826496312 pack(50425-010)
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