Label: CARROLLCLEAN (chloroxylenol- pcmx soap
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Contains inactivated NDC Code(s)
NDC Code(s): 73708-524-17 - Packager: CarrollCLEAN LCC
- 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 November 6, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Keep out of reach of children
- Directions
- Other information
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Inactive ingredients section
Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Dimethylol-5,5-dimethylhydantoin, Linear Ethoxylated Alcohol, Propylene Glycol, Polyethylene Glycol Distereate, Fragance, Tetrasodium EDTA, Methylchloroisothiazolinone (and) Methyllisothiazolinone, Isopropyl Myristate, Citric acid, FD & C Red #40, D & C Red #33
- Package label
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INGREDIENTS AND APPEARANCE
CARROLLCLEAN
chloroxylenol (pcmx) soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73708-524 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 0.282 mg in 100 mL Inactive Ingredients Ingredient Name Strength SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) 7.85 mL in 100 mL METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W) 0.099 mL in 100 mL COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 4.132 mL in 100 mL C9-11 PARETH-8 (UNII: 80E6PSE1XL) 0.242 mL in 100 mL ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.005 mL in 100 mL PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) 0.317 mL in 100 mL WATER (UNII: 059QF0KO0R) 84.307 mL in 100 mL ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.026 mL in 100 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 2.146 mL in 100 mL D&C RED NO. 33 (UNII: 9DBA0SBB0L) 0.0004 mL in 100 mL EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6) 0.038 mL in 100 mL PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.221 mL in 100 mL FD&C RED NO. 40 (UNII: WZB9127XOA) 0.0002 mL in 100 mL DMDM HYDANTOIN (UNII: BYR0546TOW) 0.334 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73708-524-17 800 mL in 1 BAG; Type 0: Not a Combination Product 11/06/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/06/2020 Labeler - CarrollCLEAN LCC (081222623) Registrant - CarrollCLEAN LCC (081222623) Establishment Name Address ID/FEI Business Operations CarrollCLEAN 081222623 manufacture(73708-524)