Label: SOOTHE RODAN FIELDS- hydrocortisone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 14222-2003-1, 14222-2003-2 - Packager: Rodan & Fields, LLC.
- 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 January 24, 2012
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
HYDROCORTISONE 1%
Keep out of reach of children.
if swallowed, get medical help or contact a poison control center immediately.
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
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INGREDIENTS AND APPEARANCE
SOOTHE RODAN FIELDS
hydrocortisone lotionProduct 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
