Label: FIXMYSKIN HEALING BALM FRAGRANCE-FREE- hydrocortisone ointment

  • NDC Code(s): 76314-002-02, 76314-002-03
  • Packager: Lovely Skin, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 30, 2023

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

  • Active Ingredient & Purpose

    Active Ingredient                                                                         Purpose Hydrocortisone 1%   ....................................................................Antipruritic, External Analgesic

  • Uses

    For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, psoriasis, seborrheic dermatitis, insect bites, poison oak, or poison sumac, soaps, detergents, cosmetics, and jewelry, and for external genital and feminine itching, and external analgesic.  Other uses of this product should only be under the advice and supervision of a doctor.

  • Warnings

    For external use only.  Avoid contact with eyes.

  • Stop use

    and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.  Any use of this product other than those listed above should be under the advice and supervision of a doctor.

  • Do not use

    for the treatment of diaper rash.  Consult a doctor.

  • Keep out of reach of children

    Keep out of reach of children

  • Directions

    For itching associated with skin irritation, inflammation and rashes:     Adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age:  do not use - consult a doctor.

  • Inactive Ingredients

    Ricinus Communis (Castor) Seed Oil, Stearyl Alcohol, C12-15 Alkyl Benzoate, Meadow Foam (Limnanthes Alba) Seed Oil, Shea Butter (Butyrospermum Parkil) Extract, Beeswax, Glycine Soja (Soybean) Germ Extract, Zea Mays (Corn) Starch, Silica, Theobroma Cacao (Cocoa) Seed Butter.

  • Questions or Comments?

    www.FixMySkin.com      Info@FixMySkin.com          (402)697-1100

  • Description

    Formulated by a board-certified dermatologist and his son.  Dr. Joel Schlessinger and his son, Daniel Schlessinger, embarked on a five year quest to find the best balm product in a stick formulation for dry skin and irritation.  After 54 different formulas, they finally came up with this patent pending formula.  It is great for dry skin and helps improve the signs and symptoms of dry skin due to eczema, medications, psoriasis and other dry skin conditions.  It is also available in the LovelySkin line without hydrocortisone (www.LovelySkin.com/Balm).  Visit www.FixMySkin.com/Story for the whole story on how this product was developed.

  • Purpose

    Antipruritic, External Analgesic

  • FixMySkin Healing Balm Fragrance-Free 0.25oz/7.39ml (76314-002-02) | FixMySkin Healing Balm Fragrance-Free 0.50oz/14.78ml (76314-002-03) Representative Labeling



    FixMySkinHealingBalmFragranceFree.25

    FixMySkinHealingBalmFragranceFree.252


    DrugFacts.25oz

  • INGREDIENTS AND APPEARANCE
    FIXMYSKIN HEALING BALM FRAGRANCE-FREE 
    hydrocortisone ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76314-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    SHEANUT OIL (UNII: O88E196QRF)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76314-002-0314.78 mL in 1 PACKAGE; Type 0: Not a Combination Product11/17/2011
    2NDC:76314-002-027.39 mL in 1 PACKAGE; Type 0: Not a Combination Product12/31/200912/31/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/31/2009
    Labeler - Lovely Skin, Inc. (968605571)
    Registrant - Lovely Skin, Inc. (968605571)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topical Pharmaceuticals Inc.831530683manufacture(76314-002)