RODAN AND FIELDS SOOTHE (HYDROCORTISONE) CREAM [COSMETIC ENTERPRISES LTD.]

RODAN AND FIELDS SOOTHE (HYDROCORTISONE) CREAM [COSMETIC ENTERPRISES LTD.]
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NDC	56152-2003-1, 56152-2003-2
Set ID	ae7efc49-19bc-415e-934f-58b22a2f54b7
Category	HUMAN OTC DRUG LABEL
Packager	Cosmetic Enterprises Ltd.
Generic Name
Product Class
Product Number
Application Number	PART333

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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
1-888-995-5656
PRINCIPAL DISPLAY PANEL

Soothe

Soothing lotion with hydrocortisone

1 fl. oz./30 mL

INGREDIENTS AND APPEARANCE

RODAN AND FIELDS SOOTHE
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:56152-2003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 mg in 100 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:56152-2003-2	1 in 1 BOX
1	NDC:56152-2003-1	30 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333	01/01/2009

Labeler - Cosmetic Enterprises Ltd. (017701475)

Registrant - Rodan & Fields LLC. (051659584)

Name	Address	ID/FEI	Business Operations
Establishment
Cosmetic Enterprises Ltd.		017701475	manufacture

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