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.
Updated March 21, 2012
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- Active Ingredient & Purpose
Active Ingredient PurposeClose
Hydrocortisone 1% ....................................................................Antipruritic, External Analgesic
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.Close
For external use only. Avoid contact with eyes.Close
- 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.Close
- Do not use
for the treatment of diaper rash. Consult a doctor.Close
- Keep out of reach of children
Keep out of reach of childrenClose
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.Close
- 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.Close
- Questions or Comments?
www.FixMySkin.com Info@FixMySkin.com (402)697-1100Close
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.Close
Antipruritic, External AnalgesicClose
- 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
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76314-002 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 1 mL in 100 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 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