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Protocoxil by Bio Ekuiliber LLC

Medically reviewed on Dec 21, 2017

Dosage form: gel
Ingredients: BENZYL ALCOHOL 100mg in 1g
Labeler: Bio Ekuiliber LLC
NDC Code: 71416-002

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.

Protocoxil

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:

PROTOCOXIL 
benzyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71416-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZYL ALCOHOL (BENZYL ALCOHOL) BENZYL ALCOHOL100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) 
WATER 
EDETATE DISODIUM ANHYDROUS 
GLYCERIN 
ISOPROPYL ALCOHOL 
MARITIME PINE 
WHITE PEPPER OIL 
.ALPHA.-TOCOPHEROL ACETATE 
TROLAMINE 
Packaging
#Item CodePackage Description
1NDC:71416-002-0047 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/09/2017
Labeler - Bio Ekuiliber LLC (080648711)

 
Bio Ekuiliber LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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