Label: SOOTHE RODAN FIELDS- hydrocortisone lotion

  • 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 January 24, 2012

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  • ACTIVE INGREDIENT

    HYDROCORTISONE 1%



    Anti- Pruritic ( Anti- Itch)

    Keep out of reach of children.

    if swallowed, get medical help or contact a poison control center immediately.

    for external use only.

    adults and children 2 years of age and older: apply to the effected area not more than 3 to 4 times daily.

    children under 2 years of age: do not use, consult a doctor.

    avoid contact with eyes.
    if conditions worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.

    Water, Alcohol Denat, Diisopropyl Adipate, Cyclopentasiloxane, Aluminum Starch Octenylsuccinate, Glycerin, Sodim Polyacrylate, Peg-100 Stearate, Aloe Barbadensis Leaf Juice, Astrocaryum Murumuru Butter, Serenoa Serrulata ( Saw Palmetto) Fruit Extract, Cholesterol/ Potassium Sulfate, Camellia Oleifera Leaf Extract, Ceteth-20, Persea Gratissima ( Avocado) Oil, Cucumis Melo ( Melon) Fruit Extract, Chamomilla Recutita ( Matricaria) Flower Oil, Ethylhexyl Stearate, Acetyl Glucosamine, Trehalose, Cholesterol, Linoleic Acid, Trideceth-6, Propylene Glycol, Dicaprylate, Caprylyl Glycol, Ethylhexylglycerin

    image of box

  • PRINCIPAL DISPLAY PANEL

    Rodan and Fields

    Soothe

    Dermatologist Developed as needed

    Hydrocortisone Lotion



    30 mL/ 1 Fl. Oz.



    image of bottle

  • INGREDIENTS AND APPEARANCE
    SOOTHE  RODAN FIELDS
    hydrocortisone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14222-2003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SAW PALMETTO (UNII: J7WWH9M8QS)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    CETETH-20 (UNII: I835H2IHHX)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    TREHALOSE (UNII: B8WCK70T7I)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    PROPYLENE GLYCOL DICAPRYLATE (UNII: 581437HWX2)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14222-2003-21 in 1 BOX
    1NDC:14222-2003-130 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/07/2011
    Labeler - Rodan & Fields, LLC. (051659584)
    Registrant - Cosmetic Enterprises Ltd (017701475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Enterprises Ltd017701475manufacture
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