Label: DR BUTLER DIAPER RASH- dimethicone 1% cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 March 22, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Dimethicone 1%

  • PURPOSE

    Skin Protectant

  • INDICATIONS & USAGE

    Helps treat and prevent diaper rash, protects minor skin irritation due to diaper rash and helps seal out wetness.

  • WARNINGS

    For external use only.

    Do not use on deep or puncture wounds, animal bites, or serious burns.

    When using this product avoid contact with 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.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, seek medical help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

  • INACTIVE INGREDIENT

    Water, glycerin, petrolatum, panthenol, stearyl alcohol, steareth-20, isopropyl palmitate, cetyl alcohol, avena sativa (oat) kernel oil, sodium hyaluronate, hamamelis virginiana (witch hzael) leaf extract, rosmarinus officinalis (rosemary) leaf extract, claendula officinalis flower extract, chamomilla recutita (matricaria) flower extract, curcuma longa (tumeric) root extract, olea europaea (olive) leaf extract, lavandula angustifolia (lavender) flower extract, helichrysum italicum extract, centella asiatica extract, panax ginseng root extract, aesculus hippocastanum (horse chestnut) extract, melaleuca alternifolia (tea tree) leaf extract, carya ovata bark extract, avena sativa (oat) kernel extract, cucumis sativus (cucumber) fruit extract, sorbitol, lecithin, xanthan gum, oleic acid, iron oxides (CI 77491), phenoxyethanol, ethylhexylglycerin, sodium chloride, colloidal oatmeal, 4-t-butylcyclohexanol, pentylene glycol, benzalkonium chloride, ceramide NP.

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    DR BUTLER DIAPER RASH 
    dimethicone 1% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70942-259
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE 350 (UNII: 2Y53S6ATLU) (DIMETHICONE 350 - UNII:2Y53S6ATLU) DIMETHICONE 3501 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SORBITOL (UNII: 506T60A25R)  
    CARYA OVATA BARK (UNII: X765CF609L)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    OATMEAL (UNII: 8PI54V663Y)  
    CUCUMBER (UNII: YY7C30VXJT)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    CHAMOMILE (UNII: FGL3685T2X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    WATER (UNII: 059QF0KO0R)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    ROSEMARY (UNII: IJ67X351P9)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C16) (UNII: F5UM2KM3W7)  
    CERAMIDE NP (UNII: 4370DF050B)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    TURMERIC (UNII: 856YO1Z64F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70942-259-0385 g in 1 CAN; Type 0: Not a Combination Product03/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01603/22/2023
    Labeler - Beyond Health P.A. (026781064)
    Registrant - Derma Care Research Labs (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs116817470manufacture(70942-259)