FixMySkin HEALING BODY BALM Fragrance-Free

FixMySkin HEALING BODY BALM Fragrance-Free by

Drug Labeling and Warnings

FixMySkin HEALING BODY BALM Fragrance-Free by is a Otc medication manufactured, distributed, or labeled by Topical Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FIXMYSKIN HEALING BODY BALM FRAGRANCE-FREE- hydrocortisone ointment 
Topical Pharmaceuticals Inc.

Disclaimer: 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.

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FixMySkin HEALING BODY BALM Fragrance-Free

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch, External Analgesic

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.

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

Directions

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

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.

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

FIXMYSKIN HEALING BODY BALM FRAGRANCE-FREE 
hydrocortisone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15478-002
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 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CASTOR OIL (UNII: D5340Y2I9G)
COCOA BUTTER (UNII: 512OYT1CRR)
STARCH, CORN (UNII: O8232NY3SJ)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
SHEANUT OIL (UNII: O88E196QRF)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SOYBEAN (UNII: L7HT8F1ZOD)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15478-002-03	14.2 g in 1 PACKAGE; Type 0: Not a Combination Product	11/17/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/17/2011

Labeler - Topical Pharmaceuticals Inc. (831530683)

Establishment
Name	Address	ID/FEI	Business Operations
Topical Pharmaceuticals Inc.		831530683	manufacture(15478-002)

Revised: 1/2021

Document Id: e87b0b4e-151e-4e61-b5fa-067df0d8ede9

34390-5

Set id: cb684f31-1a22-47f4-ae3a-3c44e62e5dc3

Version: 1

Effective Time: 20210111