Your browser does not support JavaScript! FIXMYSKIN HEALING BALM FRAGRANCE-FREE (HYDROCORTISONE) OINTMENT [LOVELY SKIN, INC.]
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FIXMYSKIN HEALING BALM FRAGRANCE-FREE (hydrocortisone) ointment
[Lovely Skin, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

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


FixMySkinHealingBalmFragranceFree.25


FixMySkinHealingBalmFragranceFree.252


DrugFacts.25oz

FIXMYSKIN HEALING BALM FRAGRANCE-FREE 
hydrocortisone ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:76314-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL 
STEARYL ALCOHOL 
ALKYL (C12-15) BENZOATE 
MEADOWFOAM SEED OIL 
SHEANUT OIL 
YELLOW WAX 
SOYBEAN 
STARCH, CORN 
SILICON DIOXIDE 
COCOA BUTTER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76314-002-0314.78 mL in 1 PACKAGE
2NDC:76314-002-027.39 mL in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34811/17/2011
Labeler - Lovely Skin, Inc. (968605571)
Registrant - Lovely Skin, Inc. (968605571)
Establishment
NameAddressID/FEIBusiness Operations
Topical Pharmaceuticals Inc.831530683manufacture

Revised: 3/2012
 
Lovely Skin, Inc.

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