SOOTHE RODAN FIELDS- hydrocortisone lotion

Soothe by

Drug Labeling and Warnings

Soothe by is a Otc medication manufactured, distributed, or labeled by Rodan & Fields, LLC. , Cosmetic Enterprises Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

Rodan and Fields

Soothe

Dermatologist Developed as needed

Hydrocortisone Lotion

30 mL/ 1 Fl. Oz.

INGREDIENTS AND APPEARANCE

SOOTHE  RODAN FIELDS
hydrocortisone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14222-2003
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-2003-2	1 in 1 BOX
1	NDC: 14222-2003-1	30 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/07/2011

Labeler - Rodan & Fields, LLC. (051659584)

Registrant - Cosmetic Enterprises Ltd (017701475)

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