Label: PC511 ANTIMICROBIAL- chloroxylenol soap
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Contains inactivated NDC Code(s)
NDC Code(s): 10685-511-17 - Packager: CARROLL COMPANY
- 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 31, 2018
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Keep out of reach of children
- Uses
- Warnings
- Directions
- Other information
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Inactive ingredients:
Water, Sodium laureth sulfate, Sodium chloride, Cocamidopropyl betaine, PEG-120 Methyl glucose dioleate, DMDM hydantoin, Linear alcohol ethoxylate, Propylene glycol, Glycol distearate, Myristyl alcohol, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance, Tetrasodium EDTA, Isopropyl myristate, Citric acid, FD&C Red #40, FD&C Red #4.
- PRINCIPAL DISPLAY PANEL - 800 mL Bag Label CLEAN N FRESH® Lotion Hand Soap Plus (Antimicrobial) 800 ml Manufactured by: CARROLL® Company Garland, TX 75041
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INGREDIENTS AND APPEARANCE
PC511 ANTIMICROBIAL
chloroxylenol soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10685-511 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 3 g in 1000 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCOL DISTEARATE (UNII: 13W7MDN21W) MYRISTYL ALCOHOL (UNII: V42034O9PU) C9-11 PARETH-6 (UNII: KCE0V8JT7W) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) DMDM HYDANTOIN (UNII: BYR0546TOW) PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V) EDETATE SODIUM (UNII: MP1J8420LU) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM CHLORIDE (UNII: 451W47IQ8X) Product Characteristics Color pink Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10685-511-17 800 mL in 1 BAG; Type 0: Not a Combination Product 10/16/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 10/16/2013 Labeler - CARROLL COMPANY (007372329)