FixMySkin HEALING BODY BALM Fragrance-Free

Manufacturer
Topical Pharmaceuticals Inc.
Effective date
2021-01-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:55:56

Label at a glance#

ProductFixMySkin HEALING BODY BALM Fragrance-Free
Active ingredientHYDROCORTISONE
Label structure8 sections

Indications and uses

• For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis and psoriasis, and for external genital and feminine itching. • Other uses of this product should be only under the advice and supervision of a doctor.

Dosage and administration

• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. • Children under 2 years of age: Do not use - consult a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Anti-itch, External Analgesic

Uses

INDICATIONS & USAGE SECTION

• For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis and psoriasis, and for external genital and feminine itching.

• Other uses of this product should be only under the advice and supervision of a doctor.

Warnings

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

• Children under 2 years of age: Do not use - consult a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

BEESWAX, C12-15 ALKYL BENZOATE, CASTOR SEED OIL (RICINUS COMMUNIS), COCOA SEED BUTTER (THEOBROMA CACAO), CORN STARCH (ZEA MAYS), MEADOW FOAM SEED OIL (LIMNANTHES ALBA), SHEA BUTTER EXTRACT (BUTYROSPERMUM PARKII), SILICA, SOYABEAN GERM EXTRACT (GLYCINE SOJA), STEARYL ALCOHOL.

SPL UNCLASSIFIED SECTION

Fragrance-free | Dermatologist-developed

Treats and soothes eczema, Psoriasis, insect bites, poison ivy

Costs less than prescription medications!

Visit FixMySkin.com for more information.

U.S Patent No. 8,685,381
Manufactured by Topical Pharmaceuticals, Inc.
1470 Bernard Dr, Addison, IL 60101
For Lovely Skin, Inc.
2929 Oak View Drive, Omaha, NE 68144

www.FixMySkin.com

Made in the USA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

Products#

Every source-derived product name is available through these pages.

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
15478-00215478-002-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e87b0b4e-151e-4e61-b5fa-067df0d8ede9cb684f31-1a22-47f4-ae3a-3c44e62e5dc32021-01-11WarningsExact identifier
spl id: e87b0b4e-151e-4e61-b5fa-067df0d8ede9
spl set id: cb684f31-1a22-47f4-ae3a-3c44e62e5dc3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.