Label: SUDS HIGH FOAMING ANTISEPTIC HAND AND BODY WASH- chloroxylenol soap

  • NDC Code(s): 63830-876-01, 63830-876-03, 63830-876-05, 63830-876-06, view more
    63830-876-07, 63830-876-08, 63830-876-09, 63830-876-10, 63830-876-11, 63830-876-12, 63830-876-13, 63830-876-14, 63830-876-15, 63830-876-16, 63830-876-17, 63830-876-18, 63830-876-19, 63830-876-20, 63830-876-24, 63830-876-27, 63830-876-28, 63830-876-35, 63830-876-55
  • Packager: Pro chem, Inc.
  • 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 January 10, 2017

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

  • Drug Facts Box OTC-Active Ingredient Section

    Chloroxylenol 0.3%

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  • Drug Facts Box OTC-Purpose Section

    Antiseptic

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  • Drug Facts Box OTC-Indications & Usage Section

    for hand-washing to decrease bacteria on the skin

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  • Drug Facts Box OTC-Warnings Section

    For external use only

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  • Drug Facts Box OTC-When Using Section

    do not get into eyes

    if contact occurs, rinse eyes thoroughly with water

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  • Drug Facts Box OTC-Stop Use Section

    irritation and redness develop

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

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

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  • 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
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  • Drug Facts Box OTC-Inactive Ingredient Section

    water, decyl glucoside, sodium laureth sulfate, cocamide MIPA, propylene glycol, DMDM hydantoin, fragrance, aloe barbadensis, acid red 1

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  • Suds High Foaming Antiseptic Hand & Body Wash 6876

    product labelSuds High Foaming Antiseptic Hand & Body Wash

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  • INGREDIENTS AND APPEARANCE
    SUDS HIGH FOAMING ANTISEPTIC HAND AND BODY WASH 
    chloroxylenol soap
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63830-876
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    ACID RED 1 (UNII: 3365R6427R)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63830-876-06 1 in 1 BOX 01/10/2017
    1 800 mL in 1 BAG; Type 0: Not a Combination Product
    2 NDC:63830-876-17 532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/10/2017
    3 NDC:63830-876-24 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/10/2017
    4 NDC:63830-876-01 1200 mL in 1 CARTRIDGE; Type 0: Not a Combination Product 01/10/2017
    5 NDC:63830-876-03 350 mL in 1 CARTRIDGE; Type 0: Not a Combination Product 01/10/2017
    6 NDC:63830-876-05 540 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/10/2017
    7 NDC:63830-876-07 700 mL in 1 BAG; Type 0: Not a Combination Product 01/10/2017
    8 NDC:63830-876-09 2000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product 01/10/2017
    9 NDC:63830-876-10 1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product 01/10/2017
    10 NDC:63830-876-11 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/10/2017
    11 NDC:63830-876-12 1000 mL in 1 BAG; Type 0: Not a Combination Product 01/10/2017
    12 NDC:63830-876-13 800 mL in 1 BAG; Type 0: Not a Combination Product 01/10/2017
    13 NDC:63830-876-14 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/10/2017
    14 NDC:63830-876-15 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/10/2017
    15 NDC:63830-876-28 149 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/10/2017
    16 NDC:63830-876-27 800 mL in 1 CARTRIDGE; Type 0: Not a Combination Product 01/10/2017
    17 NDC:63830-876-55 208200 mL in 1 DRUM; Type 0: Not a Combination Product 01/10/2017
    18 NDC:63830-876-08 1 in 1 BOX 01/10/2017
    18 1000 mL in 1 BAG; Type 0: Not a Combination Product
    19 NDC:63830-876-16 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/10/2017
    20 NDC:63830-876-18 50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/10/2017
    21 NDC:63830-876-19 18900 mL in 1 CONTAINER; Type 0: Not a Combination Product 01/10/2017
    22 NDC:63830-876-20 75600 mL in 1 DRUM; Type 0: Not a Combination Product 01/10/2017
    23 NDC:63830-876-35 132500 mL in 1 DRUM; Type 0: Not a Combination Product 01/10/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 01/10/2017
    Labeler - Pro chem, Inc. (061396065)
    Registrant - ABC Compounding Co., Inc. (003284353)
    Establishment
    Name Address ID/FEI Business Operations
    ABC Compounding Co., Inc. 003284353 manufacture(63830-876)
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