PROTOCOXIL- benzyl alcohol gel 
Bio Ekuiliber LLC

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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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:

Bottle2

PROTOCOXIL 
benzyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71416-002
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:71416-002-0047 g in 1 BOTTLE; Type 0: Not a Combination Product05/09/201711/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/09/201711/30/2018
Labeler - Bio Ekuiliber LLC (080648711)

Revised: 11/2018
Document Id: 7be95718-0882-5809-e053-2a91aa0a911e
Set id: c43b9de9-43ee-4fa0-9210-3553ea228d9c
Version: 3
Effective Time: 20181130
 
Bio Ekuiliber LLC