FixMySkin HEALING LIP BALM Unflavored

FixMySkin HEALING LIP BALM unflavoured by

Drug Labeling and Warnings

FixMySkin HEALING LIP BALM unflavoured by is a Otc medication manufactured, distributed, or labeled by Topical Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FIXMYSKIN HEALING LIP BALM UNFLAVOURED- 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 LIP BALM Unflavored

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch, External Analgesic

Use

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

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

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.

Packaging

IMAGE

FIXMYSKIN HEALING LIP BALM UNFLAVOURED 
hydrocortisone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 15478-300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 15478-300-014.25 g 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 not finalpart34811/17/2011
Labeler - Topical Pharmaceuticals Inc. (831530683)
Establishment
NameAddressID/FEIBusiness Operations
Topical Pharmaceuticals Inc.831530683manufacture(15478-300)

Revised: 1/2021
Document Id: 8b78439b-353a-4a8d-a2cb-25b8501bc6f5
Set id: ad14dc07-3a6a-4dd5-bf6b-11d62e1404e2
Version: 1
Effective Time: 20210112