Label: GOLD AND SUDSY- chloroxylenol soap
-
NDC Code(s):
52674-544-06,
52674-544-07,
52674-544-10,
52674-544-11, view more52674-544-12, 52674-544-13, 52674-544-14, 52674-544-27
- Packager: Cosgrove Enterprises, Inc.
- Category: HUMAN OTC DRUG LABEL
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 28, 2018
If you are a healthcare professional or from the pharmaceutical industry 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
- Gold & Sudsy 6544 800ml
-
INGREDIENTS AND APPEARANCE
GOLD AND SUDSY
chloroxylenol soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52674-544 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:52674-544-06 1 in 1 BOX 10/12/2015 1 800 mL in 1 BAG; Type 0: Not a Combination Product 2 NDC:52674-544-07 700 mL in 1 BAG; Type 0: Not a Combination Product 10/12/2015 3 NDC:52674-544-10 1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product 10/12/2015 4 NDC:52674-544-11 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/12/2015 5 NDC:52674-544-12 1000 mL in 1 BAG; Type 0: Not a Combination Product 10/12/2015 6 NDC:52674-544-13 800 mL in 1 BAG; Type 0: Not a Combination Product 10/12/2015 7 NDC:52674-544-14 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/12/2015 8 NDC:52674-544-27 800 mL in 1 CARTRIDGE; 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 10/12/2015 Labeler - Cosgrove Enterprises, Inc. (056128473) Registrant - ABC Compounding Co., Inc. (003284353) Establishment Name Address ID/FEI Business Operations ABC Compounding Co., Inc. 003284353 manufacture(52674-544)