Label: PC529 ULTREX- chloroxylenol soap
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Contains inactivated NDC Code(s)
NDC Code(s): 10685-529-17, 10685-529-28 - 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, Potassium Cocoate, TEA Cocoyl Hydrolyzed Collagen, hydroxyethyl Cellulose, Glycol Distearate, Sodium Laureth Sulfate, Myristyl Alcohol, Cocamidopropyl Betaine, Sodium Chloride, C9-11 Pareth-6, Fragrance, Propylene Glycol, Tetrasodium EDTA, Isopropyl Myristate, FD & C Red #40, D &C Red #33, Methylchloroisothiazolinone (and) Methylisothiazolinone.
- PRINCIPAL DISPLAY PANEL - 800 mL Bag Label CLEAN N FRESH® Ultrex Antimicrobial Hand Soap 800 ml CARROLL® Company Garland, TX 75041
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INGREDIENTS AND APPEARANCE
PC529 ULTREX
chloroxylenol soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10685-529 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 2.5 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) HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%) (UNII: X70SE62ZAR) POTASSIUM COCOATE (UNII: F8U72V8ZXP) EDETATE SODIUM (UNII: MP1J8420LU) SODIUM CHLORIDE (UNII: 451W47IQ8X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color pink Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10685-529-28 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/21/2014 2 NDC:10685-529-17 800 mL in 1 BAG; Type 0: Not a Combination Product 01/21/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 01/21/2014 Labeler - CARROLL COMPANY (007372329)