Label: CARPAL COMFORT- benzyl alchohol, lidocaine hci cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated July 10, 2019

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Benzyl Alcohol, Lidocaine HCl

  • INDICATIONS

    For temporary relief of pain.

  • WARNINGS

    • For external use only
    • Avoid contact with eyes
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, consult physician.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, contact physician prior to use.

  • STOP USE

    If symptoms persist more than seven days, discontinue use and consult physician.

  • ADDITIONAL INFORMATION

    Store at room temperature.

  • QUESTIONS

    Questions or comments? www.carpalcomfort.com

  • PURPOSE

    Topical Anesthetic

  • INDICATIONS & USAGE

    LIDOCAINE HYDROCHLORIDE

    BENZYL ALCOHOL

    POLYSORBATE 20

    PROPYLENE GLYCOL

    BOSWELLIA SERRATA RESIN OIL

    ILEX PARAGUARIENSIS LEAF

    MAGNESIUM SULFATE, UNSPECIFIED

    SPEARMINT OIL

    ALCOHOL

    TRIETHANOLAMINE SULFATE

    XANTHAN GUM

    WATER

    PHENOXYETHANOL

    ARNICA MONTANA FLOWER WATER

    DIMETHYL SULFONE

    CARBOMER 980

    ETHOXYDIGLYCOL BEHENATE

  • DOSAGE & ADMINISTRATION

    Adults and children two-years of age and older:

    Apply to affected area not more than three to four times a day.

    Children under two years of age:

    Consult a physician

  • INACTIVE INGREDIENT

    LIDOCAINE HYDROCHLORIDE

    BENZYL ALCOHOL

    POLYSORBATE 20

    PROPYLENE GLYCOL

    BOSWELLIA SERRATA RESIN OIL

    ILEX PARAGUARIENSIS LEAF

    MAGNESIUM SULFATE, UNSPECIFIED

    SPEARMINT OIL

    ALCOHOL

    TRIETHANOLAMINE SULFATE

    XANTHAN GUM

    WATER

    PHENOXYETHANOL

    ARNICA MONTANA FLOWER WATER

    DIMETHYL SULFONE

    CARBOMER 980

    ETHOXYDIGLYCOL BEHENATE

  • PRINCIPAL DISPLAY PANEL

    BottleBox

  • INGREDIENTS AND APPEARANCE
    CARPAL COMFORT 
    benzyl alchohol, lidocaine hci cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73214-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH) BENZYL ALCOHOL10 mg  in 100 mL
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ETHOXYDIGLYCOL BEHENATE (UNII: N76ISC4ZZO)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    ALCOHOL (UNII: 3K9958V90M)  
    TRIETHANOLAMINE SULFATE (UNII: MV1V89M17O)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73214-001-011 in 1 BOX07/10/2019
    188 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/10/2019
    Labeler - Comfort Lab, LP (117057860)