PREVISENSE ANTIFUNGAL MOISTURE BARRIER WITH PROTEASE TECHNOLOGY- miconazole nitrate 2.0% cream 
Molnlycke Health Care

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.

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PreviSense Antifungal Moisture Barrier with Protease Technology Sachet

Active Ingredient

Miconazole Nitrate 2.0%

Purpose

Antifungal

Uses

For the treatment of:

  • Jock itch
  • Superficial skin infections caused by yeast (Candida albicans)
  • Relieves irritation and discomfort associated with jock itch

Warnings

For external use only

Do not use

  • on children under 2 years of age unless directed by a doctor

Avoid contact with the eyes

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

  • Cleanse the affected area and dry thorougly
  • Apply a thin layer of the product over the affected area twice daily or as directed by a doctor
  • Supervise children in the use of this product
  • For jock itch, use daily for 2 weeks. If condition persists longer, stop use and consult a doctor
  • This product is not effective on the scalp or nails

Inactive Ingredients

Actinidin, Alpha Tocopherol, Bees Wax, Biotin, Bromelain, Butylene Glycol, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Citric Acid, Dimethicone, Disodium EDTA, Ergocalciferol, Ficin, Fragrance, Glutamine, Hexyl Laurate, Hydrogenated Castor Oil,
Hydroxyethylcellulose, Iodopropynyl Butylcarbamate, Isopropyl Palmitate, Methylparaben, Petrolatum, Phenoxyethanol, Polyglyceryl-4 Isostearate, Proline, Propylene Glycol, Propylparaben, Purified Water, Sodium Bisulfite, Sodium
Chloride, Sodium Hydroxide, Zinc Oxide

PreviSense Antifungal Moisture Barrier Sachet

PREVISENSE ANTIFUNGAL MOISTURE BARRIER WITH PROTEASE TECHNOLOGY 
miconazole nitrate 2.0% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0234-8578
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
ERGOCALCIFEROL (UNII: VS041H42XC)  
PROLINE (UNII: 9DLQ4CIU6V)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PETROLATUM (UNII: 4T6H12BN9U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
KIWI FRUIT (UNII: 71ES77LGJC)  
FIG (UNII: TGD87RII2U)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLUTAMINE (UNII: 0RH81L854J)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM BISULFITE (UNII: TZX5469Z6I)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
BIOTIN (UNII: 6SO6U10H04)  
BROMELAINS (UNII: U182GP2CF3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0234-8578-004 g in 1 PACKET; Type 0: Not a Combination Product04/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C04/01/201612/31/2018
Labeler - Molnlycke Health Care (165301032)

Revised: 12/2018
 
Molnlycke Health Care