Label: CETAPHIL CRACKED SKIN REPAIR BALM- dimethicone cream

  • NDC Code(s): 0299-4115-00
  • 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 ingredient......Purpose

    Dimethicone 1%......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

    BEHENYL ALCOHOL, BUTYROSPERMUM PARKII (SHEA) OIL, CAPRYLYL GLYCOL, CETEARYL ALCOHOL, CETYL ALCOHOL, CITRIC ACID, ETHYLHEXYLGLYCERIN, GLYCERIN, SODIUM CETEARYL SULFATE, SODIUM POLYACRYLATE, WATER, YEAST BETAGLUCAN

  • Questions or comments?

    1-866-735-4137

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

    All trademarks are the property of their respective owners

    Made in Canada

    cetaphil.com


  • PRINCIPLE DISPLAY PANEL - 3 oz carton

    Dermatologist Recommended
    For Sensitive Skin

    Cetaphil®

    Cracked Skin
    Repair Balm
    Skin Protectant Dimethicone

    Very Dry, Cracked Sensitive Skin

    Instantly protects and
    soothes to promote
    healing of deeply
    cracked skin


    Beta Glucan

    5 skin sensitivity signs

    NET WT 3 OZ ( 85 g)

    P56442-1

    P56442-1 carton
  • INGREDIENTS AND APPEARANCE
    CETAPHIL CRACKED SKIN REPAIR BALM 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4115
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Docosanol (UNII: 9G1OE216XY)  
    Sheanut Oil (UNII: O88E196QRF)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sodium Cetostearyl Sulfate (UNII: 7ZBS06BH4B)  
    Sodium Polyacrylate (2500000 Mw) (UNII: 05I15JNI2J)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0299-4115-001 in 1 CARTON05/01/2021
    185 g in 1 TUBE; Type 0: Not a Combination Product
    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(0299-4115)
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