RODAN AND FIELDS SOOTHE- allantoin, dimethicone cream

RODAN and FIELDS SOOTHE by

Drug Labeling and Warnings

RODAN and FIELDS SOOTHE by is a Otc medication manufactured, distributed, or labeled by Bentley Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Allantion 0.5%

Dimethicone 2.9%

PURPOSE:

Skin protectants

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

USES:

Temporarily protcts and helps relieve chapped or cracked skin. Helps protect from the drying effects of wind and cold weather.

WARNINGS:

For external use only. When using this product do not get into eyes. Stop use and ask doctor if condition worsens and symptoms last more than 7 days or clear up and occur again within a few days. Do not use on deep or puncture wounds, animal bites and serious burns.

DIRECTIONS:

Apply a generous dime-sized amount evenly over the entire face, avoiding the eye area. Do not rinse off. Use twice daily.

INACTIVE INGREDIENTS:

Water (Aqua), Glycerin, Isododecane, Sodium Acrylates Copolymer, Hydrogenated Polyisobutene, Titanium Dioxide (CI 77891), Butylene Glycol, Mica (CI 77019), Glycine Soja (Soybean) Germ Extract, PEG-40 Stearate, Phospholipids, Polysilicone-11, Caprylyl Glycol, Xanthan Gum, Chlorphenesin, 1,2-Hexanediol, Polyglyceryl-10 Stearate, Helianthus Annuus (Sunflower) Seed Oil, Linoleic Acid, Chlorhexidine Digluconate, Bisabolol, Lysolecithin, Perilla Ocymoides Seed Oil, Dimethylacrylamide/Acrylic Acid/Polystyrene Ethyl Methacrylate Copolymer, Coco-Caprylate/Caprate, Angelica Polymorpha Sinensis Root Extract, Phenoxyethanol, Honey Extract, Chamomilla Recutita (Matricaria) Flower Extract, Pelargonium Graveolens Flower Oil, Lavandula Angustifolia (Lavender) Oil, Sodium Benzoate, Oryza Sativa (Rice) Bran Extract, Boswellia Serrata Extract, Tetrapeptide-16, Tranexamic Acid, Decyl Glucoside, Oligopeptide-10, Hexylene Glycol, Tropolone, Potassium Sorbate, Tocopherol

RODAN and FIELDS SOOTHE Label

RODAN and FIELDS SOOTHE

2 Sensitive Skin Treatment

Manufactured for Rodan and Fields, LLC
San Francisco, CA 94105
Made in USA  SOTT00   85-06-00129 Please Recycle
visit rodanandfields.com

QUESTIONS OR COMMENTS
1-888-995-5656

50mL/1.7 Fl. Oz.

INGREDIENTS AND APPEARANCE

RODAN AND FIELDS SOOTHE 
allantoin, dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54111-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.25000 g  in 50 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1.45000 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISODODECANE (UNII: A8289P68Y2)
SODIUM ACRYLATE (UNII: 7C98FKB43H)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MICA (UNII: V8A1AW0880)
SOYBEAN GERM (UNII: JBW2VHD14M)
PEG-40 STEARATE (UNII: ECU18C66Q7)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
XANTHAN GUM (UNII: TTV12P4NEE)
CHLORPHENESIN (UNII: I670DAL4SZ)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)
SUNFLOWER OIL (UNII: 3W1JG795YI)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
LEVOMENOL (UNII: 24WE03BX2T)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
PERILLA FRUTESCENS SEED OIL (UNII: 322MS57V7Z)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
ANGELICA POLYMORPHA ROOT (UNII: HZ12173363)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HONEY (UNII: Y9H1V576FH)
CHAMOMILE (UNII: FGL3685T2X)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
LAVENDER OIL (UNII: ZBP1YXW0H8)
SODIUM BENZOATE (UNII: OJ245FE5EU)
RICE BRAN (UNII: R60QEP13IC)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
TRANEXAMIC ACID (UNII: 6T84R30KC1)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
TROPOLONE (UNII: 7L6DL16P1T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54111-123-50	50 mL in 1 TUBE; Type 0: Not a Combination Product	02/05/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/05/2010

Labeler - Bentley Laboratories, LLC (068351753)

Registrant - Bentley Laboratories, LLC (068351753)

Establishment
Name	Address	ID/FEI	Business Operations
Bentley Laboratories, LLC		068351753	manufacture(54111-123)