Fixmyskin Healing Balm Fragrance-free

Fixmyskin Healing Balm Fragrance-free
SPL v12
SPL
SPL Set ID c12af4c6-2f05-46ec-b901-1a4fcd750180
Route
TOPICAL
Published
Effective Date 2012-02-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Castor Oil Stearyl Alcohol Alkyl (c12-15) Benzoate Meadowfoam Seed Oil Sheanut Oil Yellow Wax Soybean Starch, Corn Silicon Dioxide Cocoa Butter

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-12-31 Until 2009-12-31

Description

Active Ingredient                                                                         Purpose Hydrocortisone 1%   ....................................................................Antipruritic, External Analgesic

Purpose

Active Ingredient                                                                         Purpose Hydrocortisone 1%   ....................................................................Antipruritic, External Analgesic


Medication Information

Purpose

Antipruritic, External Analgesic

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.

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.

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.

Warnings

For external use only.  Avoid contact with eyes.

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.

Do Not Use

for the treatment of diaper rash.  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

Active Ingredient & Purpose

Active Ingredient                                                                         Purpose Hydrocortisone 1%   ....................................................................Antipruritic, External Analgesic



Keep Out of Reach of Children

Keep out of reach of children

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







Structured Label Content

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.

Purpose

Antipruritic, External Analgesic

Stop Use (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.

Warnings

For external use only.  Avoid contact with eyes.

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.

Do Not Use (Do not use)

for the treatment of diaper rash.  Consult a doctor.

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.

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? (Questions or Comments?)

www.FixMySkin.com      [email protected]          (402)697-1100

Active Ingredient & Purpose

Active Ingredient                                                                         Purpose Hydrocortisone 1%   ....................................................................Antipruritic, External Analgesic



Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children

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 (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)







Advanced Ingredient Data


Raw Label Data

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