SANTI WASH ANTISEPTIC HAND WASH (PIVIDONE IODINE) LIQUID [ABC COMPOUNDING CO., INC.]

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SANTI WASH ANTISEPTIC HAND WASH (PIVIDONE IODINE) LIQUID [ABC COMPOUNDING CO., INC.]
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NDC 62257-275-14, 62257-275-55
Set ID be689cc6-0fb4-4d88-a854-c9e6ed5a6fd7
Category HUMAN OTC DRUG LABEL
Packager ABC Compounding Co., Inc.
Generic Name
Product Class
Product Number
Application Number PART333E
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  • Drug Facts Box OTC-Active Ingredient Section

    Povidone-Iodine, 5.0% (equivalent to 0.5% available iodine)

  • Drug Facts Box OTC-Indications & Usage Section

    For hand-washing to decrease bacteria on the skin, only when water is not available

  • Drug Facts Box OTC-Warnings Section

    For external use only

  • Drug Facts Box OTC-Purpose Section

    Antiseptic

  • Drug Facts Box-OTC When Using Section

    do not get into eyes

    if contact occurs, rinse eyes thoroughly with water

  • Drug Facts Box-OTC Stop Use Section

    irritation and redness develop

  • Drug Facts Box-OTC Keep Out Of Reach Of Children Section

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

  • Drug Facts Box-OTC Dosage & Administration Section

    wet hands and forearms
    apply 5 milliliters (teaspoonful) or palmful to hands and forearms
    scrub thoroughly for 1 minute and rinse

  • Drug Facts Box-OTC Inactive Ingredient Section

    water, sodium lauryl sulfate, glycerin, hydroxyethyl cellulose, sodium phosphate dibasic anhydrous

  • Santi Wash Antiseptic Hand Wash

    product label

    Santi Wash Antiseptic Hand Wash Label

  • INGREDIENTS AND APPEARANCE
    SANTI WASH ANTISEPTIC HAND WASH 
    pividone iodine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62257-275
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62257-275-143785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/06/2018
    2NDC:62257-275-5520820 mL in 1 DRUM; Type 0: Not a Combination Product11/06/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/06/2018
    Labeler - ABC Compounding Co., Inc. (003284353)
    Registrant - ABC Compounding Co., Inc. (003284353)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABC Compounding Co., Inc.003284353manufacture(62257-275)
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