The following Structured Product Label (SPL) was submitted to the FDA by Lovely Skin, Inc. for the product Fixmyskin Healing Balm Fragrance-free (NDC 76314-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient & purpose, uses, warnings, stop use, do not use, keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredient Purpose
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.
For external use only. Avoid contact with eyes.
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.
for the treatment of diaper rash. Consult a doctor.
Keep out of reach of children
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.
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.
www.FixMySkin.com [email protected] (402)697-1100
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.
Antipruritic, External Analgesic
* Please review the disclaimer below.
