SOOTHE RODAN FIELDS - hydrocortisone lotion 
Rodan & Fields, LLC.

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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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

Rodan and Fields

Soothe

Dermatologist Developed as needed

Hydrocortisone Lotion



30 mL/ 1 Fl. Oz.



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SOOTHE  RODAN FIELDS
hydrocortisone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14222-2003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL ADIPATE 
CYCLOMETHICONE 5 
ALUMINUM STARCH OCTENYLSUCCINATE 
GLYCERIN 
PEG-100 STEARATE 
ALOE VERA LEAF 
SAW PALMETTO 
CAMELLIA OLEIFERA LEAF 
CETETH-20 
AVOCADO OIL 
CHAMOMILE FLOWER OIL 
ETHYLHEXYL STEARATE 
N-ACETYLGLUCOSAMINE 
TREHALOSE 
CHOLESTEROL 
LINOLEIC ACID 
TRIDECETH-6 
PROPYLENE GLYCOL DICAPRYLATE 
CAPRYLYL GLYCOL 
ETHYLHEXYLGLYCERIN 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:14222-2003-21 TUBE ( TUBE) in 1 BOXcontains a TUBE (14222-2003-1)
1NDC:14222-2003-130 mL in 1 TUBEThis package is contained within the BOX (14222-2003-2)

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/FEIOperations
Cosmetic Enterprises Ltd017701475manufacture

Revised: 06/2011 Rodan & Fields, LLC.