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Balmex Diaper Rash (Chattem, Inc.)

Available Formats

Dosage Form Package Information Links
CREAM 1 TUBE in 1 CARTON (41167-0242-3) > 56 g in 1 TUBE Label Information
CREAM 1 TUBE in 1 CARTON (41167-0242-0) > 113 g in 1 TUBE Label Information
CREAM 454 g in 1 JAR (41167-0242-2) Label Information

Complete Balmex Diaper Rash Information

  • SPL UNCLASSIFIED SECTION

    Balmex Diaper Rash Cream Stick


  • Active Ingredient 

    Zinc oxide 11.3%


  • Purpose

    Skin protectant


  • Uses

    • helps treat and prevent diaper rash
    • protects chafed skin due to diaper rash and helps seal out wetness

  • Warnings

    For external use only

    When using this product

    avoid contact with eyes

    Stop use and ask a doctor if

    condition worsens or lasts more than 7 days

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately. 


  • Directions

    • change wet or 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

    beeswax, benzoic acid, dimethicone, fragrance, glycine soja (soybean) oil, magnesium aspartate, methylparaben, microcrystalline wax, mineral oil, oenothera biennis (evening primrose) seed extract, olea europaea (olive) leaf extract, panthenol potassium aspartate, potassium hydroxide, propylene glycol, propylparaben, sarcosine, sodium cocoyl amino acids, sorbitan sesquioleate, synthetic beeswax, tocopherol, water (245-230)

     

    Dist.by Chattem, Inc.
    P.O. Box 2219,
    Chattanooga,TN 37409-0219
    ©2009 Chattem, Inc.
    *patent pending
    0071602-01


     

    Balmex Diaper Rash Cream 


  • Active Ingredient

    Zinc oxide 11.3%


  • Purpose

    Skin protectant


  • Uses

    • helps treat and prevent diaper rash
    • protects chafed skin due to diaper rash and helps seal out wetness

  • Warnings

    For external use only

    When using this product

    avoid contact with eyes

    Stop use and ask a doctor if

    condition worsens or lasts more than 7 days

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away. 


  • Directions

    • change wet or 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

    • do not use if quality seal is broken
    • see bottom of carton for expiration date

  • Inactive Ingredients

    beeswax, benzoic acid, dimethicone, fragrance, glycine soja (soybean) oil, magnesium aspartate, methylparaben, microcrystalline wax, mineral oil, oenothera biennis (evening primrose) seed extract, olea europaea (olive) leaf extract, panthenol potassium aspartate, potassium hydroxide, propylene glycol, propylparaben, sarcosine, sodium cocoyl amino acids, sorbitan sesquioleate, synthetic beeswax, tocopherol, water (245-230)


    Datos del Medicamento

    Ingrediente activo

    Óxido de Cinc 11.3%

    Propósito

    Protege la Piel

    Usos

    • ayuda a tratar y prevenir las rozaduras de pañal
    • protege la piel irritada por las rozaduras de pañal y ayuda a mantener la piel seca
    • cambie los pañales mojados rápidamente
    • limpie el área del pañal y deje secar
    • aplique la crema tan frecuentemente como sea necesario, o con cada cambio de pañal, especialmente a la hora de dormir o en cualquier momento que se tenga contacto con pañales mojados durante un tiempo prolongado

    Precauciones

    Para uso externo solamente

    Cuando use este producto

    Evite el contacto con los ojos

    Deje de usarlo y consulte a su médico si

    La condición empeora o dura más de 7 dias

    Mantenga fuera del alcance de los niños.

    En caso de consumo accidental, busque ayuda médica o contacte al Centro de Control de Envenenamiento inmediatamente.

    Instrucciones de uso

    Otra información

    • no use si el sello de calidad esta rolo
    • vea la fecha de caducidad en la parte interior de la caja

    Ingredientes no activos

    Cera de abeja, acido benzoico, dimeticona, fragancia, aceite de soya (glycine soja), aspartato de magnesio, metilparabeno, cera microcrístalina, aceite mineral, extracto de onagro (oenothera biennis), extracto de hoja de olivo (olea europaea), pantenol, hidróxido de potasio, propilenglicol, propilparabén, sarcosina, aminoácidos de cocil sódico, sesquioleato de sorbitán, cera sintética de abeja, tocolerol, agua (245-230)



  • Principal Display Panel

    NEW!

    PATENTED*

    Activ

    Guard TM 

    Balmex®

    Diaper Rash Cream Stick

    ZINC OXIDE 11.3%

    Fast, No Mess

    Protection

    NET WT 2 OZ (56 g)

    0071601-01

    Principal Display Panel - Balmex Diaper Rash Cream Stick


  • Principal Display Panel

    PATENTED*

    Activ

    Guard TM 

    NEUTRALIZES IRRITANTS

    IN DIRTY DIAPERS

    Balmex®

    Diaper Rash Cream

    ZINC OXIDE 11.3%

    Crema Para Rozaduras De

    Pañal con ÓXIDO DE CINC 11.3%

    Reduces redness in

    1 diaper change

    PEDIATRICIAN

    RECOMMENDED

    Soothing Vitamins B5 and E

    Gentle on, Easy Off

    NET WT 2 OZ (56 g)

    PESO NETO 2 OZ (56 g)

    Principal Display Panel - Balmex Diaper Rash Cream 2 oz Tube


  • Principal Display Panel

    PATENTED*

    Activ

    Guard TM 

    NEUTRALIZES IRRITANTS

    IN DIRTY DIAPERS

    Balmex®

    Diaper Rash Cream

    ZINC OXIDE 11.3%

    Crema Para Rozaduras De

    Pañal con ÓXIDO DE CINC 11.3%

    Reduces redness in

    1 diaper change

    PEDIATRICIAN

    RECOMMENDED

    Soothing Vitamins B5 and E

    Gentle on, Easy Off

    NET WT 4 OZ (113 g)

    PESO NETO 4 OZ (113 g)

    Principal Display Panel - Balmex Diaper Rash Cream 4 oz Tube


  • Principal Display Panel

    PATENTED*

    Activ

    Guard TM 

    NEUTRALIZES IRRITANTS

    IN DIRTY DIAPERS

    Balmex®

    Diaper Rash Cream ZINC OXIDE 11.3%

    Crema Para Rozaduras De Pañal con ÓXIDO DE CINC 11.3%

    Reduces redness in 1 diaper change

    PEDIATRICIAN RECOMMENDED

    Soothing Vitamins B5 and E

    Gentle on, Easy Off

    NET WT 16 OZ (453 g)

    PESO NETO 16 OZ (453 g)

    Principal Display Panel - Balmex Diaper Rash Cream 16 oz Jar


  • INGREDIENTS AND APPEARANCE
    BALMEX DIAPER RASH STICK 
    zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0243
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.113 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MAGNESIUM ASPARTATE (UNII: R17X820ROL)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41167-0243-0 56 g in 1 CONTAINER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part347 12/15/2008
    BALMEX DIAPER RASH 
    zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0242
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.113 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MAGNESIUM ASPARTATE (UNII: R17X820ROL)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41167-0242-3 1 in 1 CARTON
    1 56 g in 1 TUBE
    2 NDC:41167-0242-0 1 in 1 CARTON
    2 113 g in 1 TUBE
    3 NDC:41167-0242-2 454 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part347 12/15/2008
    Labeler - Chattem, Inc. (003336013)
    Establishment
    Name Address ID/FEI Business Operations
    Chattem Plant 2 830410721 LABEL, MANUFACTURE, PACK, RECOVERY, RELABEL, REPACK