Label: CETAPHIL CRACKED SKIN REPAIR- dimethicone lotion

  • NDC Code(s): 0299-4114-00
  • Packager: Galderma Laboratories, L.P.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 30, 2023

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  • Active ingredients......Purpose

    Dimethicone 2%......Skin protectant

  • PURPOSE

  • KEEP OUT OF REACH OF CHILDREN

  • Uses

    ● helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin
    ● temporary protects minor:
       ● cuts ● scrapes ● burns
    ● helps prevent and 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 a doctor if ● condition worsens ● 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 ● serious burns

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

  • Directions

    ● Apply generously to affected area as needed

  • Inactive Ingredients

    CAPRYLIC/CAPRIC TRIGLYCERIDE, HYDROGENATED CASTOR OIL, LACTIC ACID, METHOXY PEG-22/DODECYL GLYCOL COPOLYMER, METHYLPARABEN, MINERAL OIL, OZOKERITE, PEG-2 HYDROGENATED CASTOR OIL, PEG-7 HYDROGENATED CASTOR OIL, PROPYLPARABEN, SODIUM LACTATE, SORBITAN ISOSTEARATE, UREA, WATER

  • Questions or comments?

    1-866-735-4137

    Distributed By:
    Galderma Laboratories, L.P.
    Dallas, TX 75201

    All trademarks are the property of their respective owners.

    Made in Canada

    cetaphil.com

  • PRINCIPLE DISPLAY PANEL - 16 FL OZ pump label

    Dermatologist Recommended
    For Sensitive Skin

    Cetaphil®


    Cracked Skin Repair Lotion
    Skin Protectant Dimethicone

    Rough, Cracked Sensitive Skin

    Daily use lotion is designed to hydrate
    and restore rough skin and prevent
    cracked skin from coming back.

    Urea

    5 skin sensitivity signs

    16 FL OZ (473 mL)

    P56383-1

    Cet Cracked skin lotion P56383-1
  • INGREDIENTS AND APPEARANCE
    CETAPHIL CRACKED SKIN REPAIR 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4114
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Hydrogenated Castor Oil (UNII: ZF94AP8MEY)  
    Lactic Acid, Unspecified Form (UNII: 33X04XA5AT)  
    Methoxy Peg-22/Dodecyl Glycol Copolymer (UNII: 2T6YOF5WQT)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Ceresin (UNII: Q1LS2UJO3A)  
    Peg-7 Hydrogenated Castor Oil (UNII: WE09129TH5)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Sodium Lactate (UNII: TU7HW0W0QT)  
    Sorbitan Isostearate (UNII: 01S2G2C1E4)  
    Urea (UNII: 8W8T17847W)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0299-4114-00473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01605/01/2021
    Labeler - Galderma Laboratories, L.P. (047350186)
    Establishment
    NameAddressID/FEIBusiness Operations
    G Production Inc.251676961manufacture(0299-4114)
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