RODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]

RODAN AND FIELDS SOOTHE (ALLANTOIN, DIMETHICONE) CREAM [BENTLEY LABORATORIES, LLC]
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NDC 54111-123-50
Set ID bce9a8dc-c966-4244-8d91-e85080a9136f
Category HUMAN OTC DRUG LABEL
Packager Bentley Laboratories, LLC
Generic Name
Product Class
Product Number
Application Number PART347
  • 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.

    RF SOOTHE Label

    RF SOOTHE1 Label

  • INGREDIENTS AND APPEARANCE
    RODAN AND FIELDS SOOTHE 
    allantoin, dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54111-123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.25000 g  in 50 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.45000 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54111-123-5050 mL in 1 TUBE; Type 0: Not a Combination Product02/05/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/05/2010
    Labeler - Bentley Laboratories, LLC (068351753)
    Registrant - Bentley Laboratories, LLC (068351753)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bentley Laboratories, LLC068351753manufacture(54111-123)

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