FDA Label for Fixmyskin Healing Balm Unflavored

View Indications, Usage & Precautions

Fixmyskin Healing Balm Unflavored Product Label

The following document was submitted to the FDA by the labeler of this product Lovely Skin, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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      [email protected]          (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 Unflavored 0.15Oz/4.43Ml (76314-003-01) Representative Labeling






* Please review the disclaimer below.