PROTOCOXIL- benzyl alcohol gel

Protocoxil by

Drug Labeling and Warnings

Protocoxil by is a Otc medication manufactured, distributed, or labeled by Bio Ekuiliber LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

PROTOCOXIL 
benzyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71416-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH)	BENZYL ALCOHOL	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71416-001-00	47 g in 1 BOTTLE; Type 0: Not a Combination Product	05/09/2017	10/07/2019
2	NDC: 71416-001-01	45 g in 1 BOTTLE; Type 0: Not a Combination Product	05/09/2017	10/07/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/09/2017	10/07/2021

Labeler - Bio Ekuiliber LLC (080648711)