RODAN AND FIELDS SOOTHE- hydrocortisone cream 
Cosmetic Enterprises Ltd.

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.

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Soothe

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
1-888-995-5656

Soothe

Soothing lotion with hydrocortisone

1 fl. oz./30 mL

image of front labelimage of back label

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

Revised: 7/2010
Document Id: 357d8586-c3a0-419d-ab98-5ba60caf5536
Set id: ae7efc49-19bc-415e-934f-58b22a2f54b7
Version: 4
Effective Time: 20100706
 
Cosmetic Enterprises Ltd.