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
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- Official Label (Printer Friendly)
- Active Ingredient & Purpose
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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.
- Warnings
- Stop use
- Do not use
- Keep out of reach of children
- Directions
- Inactive Ingredients
- Questions or Comments?
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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.
- Purpose
- 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
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INGREDIENTS AND APPEARANCE
FIXMYSKIN HEALING BALM FRAGRANCE-FREE
hydrocortisone ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76314-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:76314-002-03 14.78 mL in 1 PACKAGE; Type 0: Not a Combination Product 11/17/2011 2 NDC:76314-002-02 7.39 mL in 1 PACKAGE; Type 0: Not a Combination Product 12/31/2009 12/31/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 12/31/2009 Labeler - Lovely Skin, Inc. (968605571) Registrant - Lovely Skin, Inc. (968605571) Establishment Name Address ID/FEI Business Operations Topical Pharmaceuticals Inc. 831530683 manufacture(76314-002)