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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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

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

Labeler - Bio Ekuiliber LLC (080648711)

Protocoxil