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
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/12

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

  • Active Ingredient & Purpose

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

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  • 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.

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  • Warnings

    For external use only.  Avoid contact with eyes.

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  • 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.

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  • Do not use

    for the treatment of diaper rash.  Consult a doctor.

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  • Keep out of reach of children

    Keep out of reach of children

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  • 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.

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  • 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.

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  • Questions or Comments?

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

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  • 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.

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  • Purpose

    Antipruritic, External Analgesic

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  • 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
  • INGREDIENTS AND APPEARANCE
    FIXMYSKIN HEALING BALM FRAGRANCE-FREE 
    hydrocortisone ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:76314-002
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 1 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    CASTOR OIL  
    STEARYL ALCOHOL  
    ALKYL (C12-15) BENZOATE  
    MEADOWFOAM SEED OIL  
    SHEANUT OIL  
    YELLOW WAX  
    SOYBEAN  
    STARCH, CORN  
    SILICON DIOXIDE  
    COCOA BUTTER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76314-002-03 14.78 mL in 1 PACKAGE
    2 NDC:76314-002-02 7.39 mL in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part348 11/17/2011
    Labeler - Lovely Skin, Inc. (968605571)
    Registrant - Lovely Skin, Inc. (968605571)
    Establishment
    Name Address ID/FEI Business Operations
    Topical Pharmaceuticals Inc. 831530683 manufacture
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