Label: COOLBOTTOMS- dimethicone cream

  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated November 19, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Dimethicone 1%

  • Purpose

    Skin protectant

  • Uses

    • helps treat diaper rash
    • temporarily protects and helps relieve chapped or cracked skin
    • protects chafed skin as associated with diaper rash and helps seal out wetness
  • Warnings

    For external use only

    When Using This Product

    • Keep out of eyes.
      Rinse eyes thoroughly with water to remove.

    Stop use and ask a doctor if:

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

    Keep out of reach of children.

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

  • Directions

    • change wet and soiled diapers promptly
    • cleanse the diaper area
    • allow to dry
    • apply cream liberally as often as necessary, especially at bedtime when exposure to wet diapers may be prolonged.
  • Inactive Ingredients

    Water, Mineral Oil, White Petrolatum, Sorbitol, Ceresine, Sorbitan Sesquioleate, Lanolin Alcohol, Phenoxyethanol, Magnesium Hydroxide, Ethylhexylglycerin, BHT

  • Questions?

    M-F CST Call: 1-877-725-RASH

  • SPL UNCLASSIFIED SECTION

    Distributed by
    GinJen
    Hammond, LA 70401

  • PRINCIPAL DISPLAY PANEL - 57g jar carton

    developed by a
    pediatrician

    PATENTED
    Cool
    bottoms®
    DIAPER RASH CREAM
    skin protectant
    cools and soothes

    NET WT 2 OZ (57g)

    Principal Display Panel - 57g jar carton
  • INGREDIENTS AND APPEARANCE
    COOLBOTTOMS   DIAPER RASH
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50952-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone0.57 g  in 57 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Sorbitol (UNII: 506T60A25R)  
    Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)  
    Lanolin Alcohols (UNII: 884C3FA9HE)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Magnesium Hydroxide (UNII: NBZ3QY004S)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50952-001-044 in 1 BOX
    128 g in 1 JAR
    2NDC:50952-001-058 in 1 BOX
    228 g in 1 JAR
    3NDC:50952-001-0612 in 1 BOX
    328 g in 1 JAR
    4NDC:50952-001-0724 in 1 BOX
    428 g in 1 JAR
    5NDC:50952-001-011 in 1 BOX
    557 g in 1 JAR
    6NDC:50952-001-0212 in 1 BOX
    657 g in 1 JAR
    7NDC:50952-001-0324 in 1 BOX
    757 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/25/2010
    Labeler - pH R&D LLC (833115764)
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