Label: PROTOCOXIL- benzyl alcohol gel

  • 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 November 27, 2020

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  • Drug Facts

  • Active ingredients

    Benzyl alcohol 10%

    Purpose

    External analgesic

  • Use

    • for the temporary relief of pain and itching associated with minor skin irritations
  • Warnings

    For external use only

    Do not use

    • in the eyes

    Stop use and ask a doctor if

    • condition worsens
    • if symptoms persist for more than 7 days
    • if symptoms clear up and occur again within a few days

    Keep out of reach of children.

    If swallowed, get medical help or contact Poison Control Center right away.

  • 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: consult a physician
  • Other information

    • protect this product from excessive heat and direct sun
  • Inactive ingredients

    acrylates/C10-30 alkyl acrylate crosspolymer, aqua (deionized water), disodium EDTA, glycerin, isopropyl alcohol, pinus pinaster bark extract, piper nigrum (pepper) seed oil, tocopheryl acetate, triethanolamine

  • Questions or comments?

    Call 786-230-6366 Monday to Friday, 9 am to 5 pm EST

  • Package Labeling:

    v1v2

  • INGREDIENTS AND APPEARANCE
    PROTOCOXIL 
    benzyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71416-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH) BENZYL ALCOHOL100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MARITIME PINE (UNII: 50JZ5Z98QY)  
    WHITE PEPPER OIL (UNII: 2AM83DL9FV)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71416-001-0047 g in 1 BOTTLE; Type 0: Not a Combination Product05/09/201710/07/2019
    2NDC:71416-001-0145 g in 1 BOTTLE; Type 0: Not a Combination Product05/09/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/09/2017
    Labeler - Bio Ekuiliber LLC (080648711)
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