Label: RODAN AND FIELDS SOOTHE- hydrocortisone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 July 6, 2010

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  • ACTIVE INGREDIENT

    Active Ingredients                 

    Hydrocortisone 1%

    Warnings: for external adult use only. Avoid contact with eyes. If condition 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.

    Purpose: for temporary relief of irritations, itching and redness.

    Questions or Comments
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  • PRINCIPAL DISPLAY PANEL

    Soothe

    Soothing lotion with hydrocortisone

    1 fl. oz./30 mL

    image of front labelimage of back label

  • INGREDIENTS AND APPEARANCE
    RODAN AND FIELDS  SOOTHE
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56152-2003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 mg  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56152-2003-21 in 1 BOX
    1NDC:56152-2003-130 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33301/01/2009
    Labeler - Cosmetic Enterprises Ltd. (017701475)
    Registrant - Rodan & Fields LLC. (051659584)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Enterprises Ltd.017701475manufacture
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