FIXMYSKIN HEALING BALM FRAGRANCE-FREE- hydrocortisone ointment

FixMySkin Healing Balm Fragrance-Free by

Drug Labeling and Warnings

FixMySkin Healing Balm Fragrance-Free by is a Otc medication manufactured, distributed, or labeled by Lovely Skin, Inc., Topical Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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      Info@FixMySkin.com          (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 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	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	11/17/2011	02/28/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not 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(76314-002)