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
  • 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 October 27, 2022

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  • Active Ingredients

    Dimethicone 28%

    Petrolatum 48%

  • Purpose

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

    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 finalM01611/07/2022
    Labeler - Ferndale Laboratories, Inc. (005320536)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ferndale Laboratories, Inc.005320536manufacture(0496-0590)
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