Label: PROVON ANTIMICROBIAL LTN SP WITH 0.3% PCMX- chloroxylenol liquid
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NDC Code(s):
21749-750-04,
21749-750-08,
21749-750-10,
21749-750-12, view more21749-750-16, 21749-750-20, 21749-750-37, 21749-750-50, 21749-750-80
- Packager: GOJO Industries, 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 September 15, 2017
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- Active ingredient
- Purpose
- Use
- Warnings
- Directions
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PROVON ANTIMICROBIAL LTN SP WITH 0.3% PCMX
chloroxylenol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21749-750 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chloroxylenol (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) Chloroxylenol 0.003 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Coconut Acid (UNII: 40U37V505D) Oleic Acid (UNII: 2UMI9U37CP) Sodium Sulfate (UNII: 0YPR65R21J) MONOETHANOLAMINE (UNII: 5KV86114PT) COCO MONOETHANOLAMIDE (UNII: C80684146D) Coco-Betaine (UNII: 03DH2IZ3FY) Propylene Glycol (UNII: 6DC9Q167V3) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) EDETATE SODIUM (UNII: MP1J8420LU) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CORN OIL (UNII: 8470G57WFM) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21749-750-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/31/2013 2 NDC:21749-750-08 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/31/2013 3 NDC:21749-750-12 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/31/2013 4 NDC:21749-750-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/31/2013 5 NDC:21749-750-50 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/31/2013 6 NDC:21749-750-80 800 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/31/2013 7 NDC:21749-750-10 1000 mL in 1 BAG; Type 0: Not a Combination Product 08/31/2013 8 NDC:21749-750-20 2000 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/31/2013 9 NDC:21749-750-37 3784 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/31/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 08/31/2013 Labeler - GOJO Industries, Inc. (004162038) Establishment Name Address ID/FEI Business Operations GOJO Industries, Inc. 036424534 manufacture(21749-750) Establishment Name Address ID/FEI Business Operations GOJO Industries, Inc. 088312414 label(21749-750) , pack(21749-750)