PREVISENSE MOISTURE BARRIER CREAM- dimethicone 5% 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 Moisture Barrier Cream 2oz

Active Ingredients

Dimethicone 5.0%

Purpose

Skin Protectant

Uses

  • Temporarily protects and helps relieve chapped or cracked skin
  • Helps treat and prevent diaper dermatitis
  • Protects minor skin irritation associated with diaper dermatitis and helps protect from wetness

For external use only

Do not use

  • on deep or puncture wounds
  • on animal bites
  • on serious burns

Avoid contact with the eyes

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again withn a few days

Keep this and all drugs out of the reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

Directions

  • Apply as needed
  • Change wet and soiled diapers promptly, cleanse the diaper area and allow to dry. Apply cream liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Inactive Ingredients

Bees Wax, Cetyl Dimethicone, Cetyl PEG/PPG-10 Dimethicone, Disodium EDTA, Hydrogenated Castor Oil, Isopropyl Palmitate, Methylparaben, Petrolatum, Propylene Glycol, Propylparaben, Purified Water, Sodium Chloride, Zinc Oxide

PreviSense Moisture Barrier Cream 2 oz

PREVISENSE MOISTURE BARRIER CREAM 
dimethicone 5% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0234-8200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0234-8200-0259 g in 1 TUBE; Type 0: Not a Combination Product04/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/01/201612/31/2018
Labeler - Molnlycke Health Care (165301032)

Revised: 12/2018
 
Molnlycke Health Care