FIXMYSKIN HEALING BALM VANILLA FLAVOR- hydrocortisone ointment 
Lovely Skin, Inc.

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FixMySkin Healing Balm Vanilla Flavor

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, Vanilla Flavor.

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 Vanilla Flavor 0.15oz/4.43ml (76314-004-01) Representative Labeling

123

FIXMYSKIN HEALING BALM VANILLA FLAVOR 
hydrocortisone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76314-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
VANILLA (UNII: Q74T35078H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76314-004-014.43 mL in 1 PACKAGE; Type 0: Not a Combination Product11/17/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01711/17/2011
Labeler - Lovely Skin, Inc. (968605571)
Registrant - Lovely Skin, Inc. (968605571)
Establishment
NameAddressID/FEIBusiness Operations
Topical Pharmaceuticals Inc.831530683manufacture(76314-004)

Revised: 11/2023
Document Id: 0b58fdc4-2027-6467-e063-6294a90abd33
Set id: 52f7a561-a0b5-4562-a588-d74fd874b83a
Version: 5
Effective Time: 20231130
 
Lovely Skin, Inc.