Label: DR. MOM BUTT BALM- dimethicone petrolatum ointment

  • NDC Code(s): 0496-0590-02
  • Packager: Ferndale Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 13, 2024

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  • Active Ingredients

    Dimethicone 28%

    White Petrolatum 48%

  • Purpose

    Dimethicone 28%..........Skin protectant

    White Petrolatum 48%............Skin protectant

  • Uses

    • helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin
  • 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 as needed
  • Other information

    Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

  • Inactive Ingredients

    aluminum starch octenylsuccinate, fractionated coconut oil, magnesium hydroxide, spearmint oil

  • Questions?

    Toll free (888) 548-0900

  • Package Display

    Dr. Mom Butt Balm Carton

  • INGREDIENTS AND APPEARANCE
    DR. MOM BUTT BALM 
    dimethicone petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0496-0590
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.28 g  in 1 g
    WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4) WHITE PETROLATUM0.48 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0496-0590-0270 g in 1 TUBE; Type 0: Not a Combination Product11/07/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01611/07/2022
    Labeler - Ferndale Laboratories, Inc. (005320536)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ferndale Laboratories, Inc.005320536manufacture(0496-0590)
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