Label: SURGENT ANTISEPTIC- chloroxylenol soap
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NDC Code(s):
66155-544-01,
66155-544-03,
66155-544-05,
66155-544-06, view more66155-544-07, 66155-544-08, 66155-544-09, 66155-544-10, 66155-544-11, 66155-544-12, 66155-544-13, 66155-544-14, 66155-544-15, 66155-544-16, 66155-544-17, 66155-544-18, 66155-544-19, 66155-544-20, 66155-544-24, 66155-544-27, 66155-544-28, 66155-544-35, 66155-544-55
- Packager: SunCoast Paper 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 December 27, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts Box OTC-Active Ingredient Section
- Drug Facts Box OTC-Purpose Section
- Drug Facts Box OTC-Indications & Usage Section
- Drug Facts Box OTC-Warnings Section
- Drug Facts Box OTC-When Using Section
- Drug Facts Box OTC-Stop Use Section
- Drug Facts Box OTC-Keep Out of Reach of Children Section
- Drug Facts Box OTC-Dosage & Administration Section
- Drug Facts Box OTC-Inactive Ingredient Section
- Surgent Antiseptic Hand Soap 800 mL
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INGREDIENTS AND APPEARANCE
SURGENT ANTISEPTIC
chloroxylenol soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66155-544 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) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) SODIUM CHLORIDE (UNII: 451W47IQ8X) DMDM HYDANTOIN (UNII: BYR0546TOW) COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66155-544-06 1 in 1 BOX 10/12/2015 1 800 mL in 1 BAG; Type 0: Not a Combination Product 2 NDC:66155-544-17 532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/12/2015 3 NDC:66155-544-24 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/12/2015 4 NDC:66155-544-01 1200 mL in 1 CARTRIDGE; Type 0: Not a Combination Product 10/12/2015 5 NDC:66155-544-03 350 mL in 1 CARTRIDGE; Type 0: Not a Combination Product 10/12/2015 6 NDC:66155-544-05 540 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/12/2015 7 NDC:66155-544-07 700 mL in 1 BAG; Type 0: Not a Combination Product 10/12/2015 8 NDC:66155-544-09 2000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product 10/12/2015 9 NDC:66155-544-10 1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product 10/12/2015 10 NDC:66155-544-11 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/12/2015 11 NDC:66155-544-12 1000 mL in 1 BAG; Type 0: Not a Combination Product 10/12/2015 12 NDC:66155-544-13 800 mL in 1 BAG; Type 0: Not a Combination Product 10/12/2015 13 NDC:66155-544-14 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/12/2015 14 NDC:66155-544-15 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/12/2015 15 NDC:66155-544-28 149 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/12/2015 16 NDC:66155-544-27 800 mL in 1 CARTRIDGE; Type 0: Not a Combination Product 10/12/2015 17 NDC:66155-544-55 208200 mL in 1 DRUM; Type 0: Not a Combination Product 10/12/2015 18 NDC:66155-544-08 1 in 1 BOX 10/12/2015 18 1000 mL in 1 BAG; Type 0: Not a Combination Product 19 NDC:66155-544-16 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/12/2015 20 NDC:66155-544-18 50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/12/2015 21 NDC:66155-544-19 18900 mL in 1 CONTAINER; Type 0: Not a Combination Product 10/12/2015 22 NDC:66155-544-20 75600 mL in 1 DRUM; Type 0: Not a Combination Product 10/12/2015 23 NDC:66155-544-35 132500 mL in 1 DRUM; Type 0: Not a Combination Product 10/12/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 03/01/2012 Labeler - SunCoast Paper Inc. (031211089) Registrant - ABC Compounding Co., Inc. (003284353) Establishment Name Address ID/FEI Business Operations ABC Compounding Co., Inc. 003284353 manufacture(66155-544)