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Barriere (WellSpring Pharmaceutical Corporation)

Available Formats

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CREAM 100 g in 1 TUBE (65197-426-01) Label Information

Complete Barriere Information

  • Active ingredient

    Dimethicone, 20%


  • Purpose

    Skin Protectant


  • Use

    â–ª Temporarily protects and helps relieve chapped or cracked skin

    â–ª Helps protect from the drying effects of wind and cold weather

    â–ª Helps treat and prevent diaper rash

    â–ª Protects minor skin irritation due to diaper rash and helps seal out wetness


  • Warning

     â–ª For external use only

    Do not use on

    â–ª Animal bites

    â–ª Deep or puncture wounds    

    â–ª Serious burns

    When using this product

    â–ª  do not get into eyes

    Stop use and ask a doctor if

    â–ª Condition worsens                                      

    â–ª Symptoms last more than 7 days or clear up and occur again within a few days

    Keep out of reach of children

  • Directions

    â–ª For Skin Protection: Apply as needed      

    â–ª For Treatment or Prevention of Diaper Rash: 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.


  • Other information

    â–ª Store at 20-25°C (68-77°F)


  • Inactive ingredients

    butylated hydroxytoluene, butylparaben, cetyl alcohol, edetate disodium, ethylparaben, fragrance, isobutylparaben, methylparaben, phenoxyethanol, propylene glycol, propylparaben, stearic acid, triethanolamine, water


  • Questions?

    Call 1-866-337-4500


  • Distributed by

    WellSpring Pharmaceutical Corporation
    Sarasota, FL 34243 USA
    (c) WellSpring 2010


  • Package Label. Principal Display Panel

    Tube label

  • INGREDIENTS AND APPEARANCE
    BARRIERE 
    dimethicone cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:65197-426
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 0.2 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color WHITE (white) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65197-426-01 100 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part347 08/02/2010
    Labeler - WellSpring Pharmaceutical Corporation (110999054)
    Establishment
    Name Address ID/FEI Business Operations
    WellSpring Pharmaceutical Canada Corp. 251086799 ANALYSIS, LABEL, MANUFACTURE, PACK
    Establishment
    Name Address ID/FEI Business Operations
    WellSpring Pharmaceutical Corporation 110999054 MANUFACTURE