PREVISENSE MOISTURE BARRIER WITH PROTEASE TECHNOLOGY- zinc oxide 7.5% 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 with Protease Technology Sachet

Active Ingredient

Zinc Oxide 7.5%

Purpose

Skin Protectant

Uses

  • Helps treat and prevent diaper dermatitis
  • Protects minor skin irritation associated with diaper dermatitis and helps protect from wetness

Warnings

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 within 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

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

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

PreviSense Moisture Barrier with Protease Sachet

PREVISENSE MOISTURE BARRIER WITH PROTEASE TECHNOLOGY 
zinc oxide 7.5% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0234-8576
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PETROLATUM (UNII: 4T6H12BN9U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
PROLINE (UNII: 9DLQ4CIU6V)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM BISULFITE (UNII: TZX5469Z6I)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
GLUTAMINE (UNII: 0RH81L854J)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
KIWI FRUIT (UNII: 71ES77LGJC)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
FIG (UNII: TGD87RII2U)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
BIOTIN (UNII: 6SO6U10H04)  
BROMELAINS (UNII: U182GP2CF3)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ERGOCALCIFEROL (UNII: VS041H42XC)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
WATER (UNII: 059QF0KO0R)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0234-8576-004 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 not finalpart35204/01/201612/31/2018
Labeler - Molnlycke Health Care (165301032)

Revised: 12/2018
 
Molnlycke Health Care